VIOLIN: Vaccine Investigation and Online Information Network

Corynebacterium diphtheriae

Table of Contents

General Information
Vaccine Related Pathogen Genes
1. tox (Protective antigen)
Vaccine Information
References

I. General Information

1. NCBI Taxonomy ID:

1717

2. Disease:

Diphtheria

3. Introduction

Corynebacterium diphtheriae is an aerobic Gram-positive bacterium that causes diphtheria in humans. Respiratory diphtheria is an upper respiratory tract illness characterized by a sore throat with low-grade fever and an adherent membrane of the tonsils, pharynx, or nose. Neck swelling is usually present in severe disease. Cutaneous diphtheria presents as infected skin lesions which lack a characteristic appearance (CDC: Diphtheria).

4. Microbial Pathogenesis

Diptheria as a disease presents itself in two forms: respiratory and cutaneous. Cutaneous diphtheria can be caused by both the toxigenic and the nontoxigenic strains of C. diphtheriae. Cutaneous diphtheria presents as nondescript sores or shallow ulcers on the skin, and is usually mild and treatable. Only 1-2% of cutaneous cases become toxigenic. Respiratory diphtheria is caused by C. diphtheriae bacteria adhering to and colonizing the tonsils, nasal cavity, and throat. Mechanisms of adherence are unknown, but recent research suggests that proteins SpaB and SpaC found on two minor pili play an important role in specifically binding to pharyngeal cells. A visible, leathery pseudomembrane forms over the surface of the cells, especially the tonsils and throat. A lesion develops and plasma from injured epithelial cells leaks into the lesion, producing a fibrin network infused with C. diphtheriae. Symptoms present themselves 2-5 days after infection with C. diphtheriae. Initially, symptoms include a sore throat and low fever. More severe symptoms include inflammation of the neck and difficulty breathing or asphyxiation (MicrobeWiki: C. diphtheriae).

5. Host Ranges and Animal Models

C. diphtheriae is only found in the mouth, throat, nose, skin, bodily secretions, and wounds of infected persons. Animals do not easily contract Diphtheria from human beings, and naturally have immunity (MicrobeWiki: C. diphtheriae).

6. Host Protective Immunity

Acquired immunity to diphtheria is due primarily to toxin-neutralizing antibody (antitoxin). Passive immunity in utero is acquired transplacentally and can last at most 1 or 2 years after birth. In areas where diphtheria is endemic and mass immunization is not practiced, most young children are highly susceptible to infection. Probably, active immunity can be produced by a mild or inapparent infection in infants who retain some maternal immunity, and in adults infected with strains of low virulence (inapparent infections) (Textbook of Bacteriology).

II. Vaccine Related Pathogen Genes

1. tox

Gene Name : tox
Sequence Strain (Species/Organism) : Corynebacterium diphtheriae
VO ID : VO_0011287
NCBI Protein GI : 38199106
Other Database IDs : CDD:280859
CDD:238651
CDD:280860
CDD:279642
GOA:Q6NK15
InterPro: IPR000512
InterPro: IPR022404
InterPro: IPR022405
InterPro: IPR022406
UniProtKB/TrEMBL: Q6NK15
Taxonomy ID : 1717
Gene Strand (Orientation) : ?
Protein Name : Diphtheria toxin precursor
Protein pI : 6.37
Protein Weight : 56772.07
Protein Length : 638
Protein Note : biotype gravis

Protein Sequence : Show Sequence

>CAE48728.1 Diphtheria toxin precursor [Corynebacterium diphtheriae]
MSRKLFASILIGALLGIGAPPSAHAGADDVVDSSKSFVMENFSSYHGTKPGYVDSIQKGIQKPKSGTQGN
YDDDWKGFYSTDNKYDAAGYSVDNENPLSGKAGGVVKVTYPGLTKVLALKVDNAETIKKELGLSLTEPLM
EQVGTEEFIKRFGDGASRVVLSLPFAEGSSSVEYINNWEQAKALSVELEINFETRGKRGQDAMYEYMAQA
CAGNRVRRSVGSSLSCINLDWDVIRDKTKTKIESLKEHGPIKNKMSESPNKTVSEEKAKQYLEEFHQTAL
EHPELSELKTVTGTNPVFAGANYAAWAVNVAQVIDSETADNLEKTTAALSILPGIGSVMGIADGAVHHNT
EEIVAQSIALSSLMVAQAIPLVGELVDIGFAAYNFVESIINLFQVVHNSYNRPAYSPGHKTQPFLHDGYA
VSWNTVEDSIIRTGFQGESGHDIKITAENTPLPIAGVLLPTIPGKLDVNKSKTHISVNGRKIRMRCRAID
GDVTFCRPKSPVYVGNGVHANLHVAFHRSSSEKIHSNEISSDSIGVLGYQKTVDHTKVNSKLSLFFEIKS

Molecule Role : Protective antigen
Molecule Role Annotation : In 1923, it was discovered that treatment with formalin eliminated the toxicity of diphtheria toxin (DT) without destroying its immunogenicity. Formalin‐treated DT, now called diphtheria toxoid, rapidly became the preferred vaccine against diphtheria, and diphtheria toxoid (usually in combined vaccines, such as diphtheria‐tetanus toxoids–pertussis vaccine [DTP] or diphtheria‐tetanus toxoids–acellular pertussis vaccine [DTaP] for children and tetanus‐diphtheria toxoids vaccine for adults [Td]) is still used throughout the world for active immunization against diphtheria (Holmes, 2000).

III. Vaccine Information

1. Actacel

a. Product Name:

Diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b conjugate vaccine

b. Tradename:

Actacel

c. Manufacturer:

Sanofi Pasteur Ltd

d. Vaccine Ontology ID:

VO_0010705

e. Type:

Subunit vaccine

f. Status:

Licensed

g. Location Licensed:

Canada

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000128

j. Preservative:

2 phenoxy ethanol

k. Immunization Route

Intramuscular injection (i.m.)

l. Storage

Refrigerate at 2° to 8°C.

m . Approved Age for Licensed Use

2 months to 7 years

n. Description

Products: Proteins + Conjugate.

2. Adacel

a. Product Name:

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

b. Tradename:

Adacel

c. Manufacturer:

Sanofi Pasteur, Ltd (USA: License #1726)

d. Vaccine Ontology ID:

VO_0000005

e. CDC CVX code:

20, 115

f. Type:

Toxoid vaccine

g. Status:

Licensed

h. Location Licensed:

USA: License #1726

i. Host Species for Licensed Use:

Human

j. Antigen

Pertussis

k. Adjuvant:

VO ID: VO_0000128
Description: It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.

l. Preparation

Corynebacterium diphtheriae is grown in modified Mueller‘s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Diphtheria toxoid is adsorbed onto aluminum phosphate (Adacel).

m. Immunization Route

Intramuscular injection (i.m.)

n. Storage

Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE

o . Approved Age for Licensed Use

Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.

p. Contraindication

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine or any other tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to vaccination with Adacel vaccine (Adacel).

q. Description

It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.

r. Human Response

Vaccination Protocol: The principal immunogenicity study was a comparative, multi-center, randomized, observer blind, controlled trial which enrolled 4,480 participants; 2,053 adolescents (11-17 years of age). and 2,427 adults (18-64 years of age). Enrollment was stratified by age to ensure adequate representation across the entire age range. Participants had not received a tetanus or diphtheria toxoid containing vaccine within the previous 5 years (Adacel).
Immune Response: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response. (Adacel)
Side Effects: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine. Also, headache, body ache or muscle weakness, tiredness, chills, sore and swollen joints, nausea, lymph node swelling, diarrhea, vomiting, and rash may result (Adacel).

3. Adacel-Polio

a. Product Name:

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

b. Tradename:

Adacel-Polio

c. Manufacturer:

Sanofi Pasteur SA

d. Type:

Toxoid vaccine + Subunit vaccine + Inactivated or "killed" vaccine

e. Status:

Licensed

f. Location Licensed:

Canada

g. Host Species for Licensed Use:

Human

h. Preservative:

2-phenoxyethanol

i. Allergen:

Neomycin, Polymyxin B, Streptomycin

j. Immunization Route

Intramuscular injection (i.m.)

k. Storage

Store at 2° to 8°C (35° to 46°F), do not freeze.

l . Approved Age for Licensed Use

4 years and older.

m. Description

ADACEL®-POLIO is a sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids and acellular pertussis vaccine adsorbed separately on aluminum phosphate and combined with inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3, and suspended in water for injection. Acellular pertussis vaccine is composed of five purified pertussis antigens (PT, FHA, PRN and FIM). (Product Monograph: Adacel-Polio)

4. Boostrix

a. Product Name:

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

b. Tradename:

Boostrix

c. Manufacturer:

GlaxoSmithKline Biologicals

d. Vaccine Ontology ID:

VO_0000015

e. CDC CVX code:

20, 115

f. Type:

Toxoid vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1617)

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0000128
Description: BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (Boostrix).

k. Preparation

Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking.
The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The bovine materials used in this extract are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). The diphtheria toxin is detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration .

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.

n . Approved Age for Licensed Use

BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose. BOOSTRIX is approved for use in individuals 10 through 64 years of age (Boostrix).

o. Contraindication

A severe allergic reaction after a previous dose of any tetanus toxoid-diphtheria toxoid or pertussis antigen containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX (Boostrix).

p. Description

BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (Boostrix).

q. Human Response

Vaccination Protocol: In a randomized, observer-blinded, controlled study in the US, 3,080 adolescents 10 to 18 years of age received a single dose of BOOSTRIX and 1,034 received the control Td vaccine (Boostrix).
Immune Response: Prior to vaccination, antibody levels in subjects were 85.8% while after vaccination were 99.9% (Boostrix).
Side Effects: Common solicited adverse events (≥15%) in adolescents were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, and gastrointestinal symptoms.(Boostrix)

5. Boostrix-Polio

a. Product Name:

Combined diphtheria, tetanus, acellular pertussis (adsorbed) and inactivated poliomyelitis vaccine

b. Tradename:

Boostrix-Polio

c. Manufacturer:

GlaxoSmithKline

d. Type:

Toxoid vaccine + Subunit vaccine + Inactivated or "killed" vaccine

e. Status:

Licensed

f. Location Licensed:

Canada

g. Host Species for Licensed Use:

Human

h. Allergen:

Neomycin, Polymyxin B

i. Immunization Route

Intramuscular injection (i.m.)

j. Storage

Store at 2° to 8°C (35° to 46°F), do not freeze.

k . Approved Age for Licensed Use

4 years of age and older.

l. Description

BOOSTRIX®-POLIO (combined diphtheria, tetanus, acellular pertussis and inactivated poliomyetitis) vaccine contains diphtheria toxoid, tetanus toxoid, three purified pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (69 kDalton outer membrane protein)] adsorbed onto aluminum salts and inactivated polio virus types 1, 2 and 3. (GSK: Boostrix-Polio)

6. DAPTACEL

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

b. Tradename:

DAPTACEL

c. Manufacturer:

Sanofi Pasteur, Ltd.

d. Vaccine Ontology ID:

VO_0000029

e. CDC CVX code:

20, 106

f. Type:

Toxoid vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1726)

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0000127
Description: DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age.

k. Preparation

DAPTACEL vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria toxoids adsorbed on aluminum phosphate. Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered (FDA: DAPTACEL).

l. Storage

DAPTACEL vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE

m . Approved Age for Licensed Use

DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday) (FDA: DAPTACEL).

n. Contraindication

Severe allergic reaction (e.g. anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, or any component of DAPTACEL, encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause and, progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized (FDA: DAPTACEL).

o. Description

DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age.

p. Human Response

Vaccination Protocol: In a randomized, double-blinded pertussis vaccine efficacy trial, the Sweden I Efficacy Trial, conducted in Sweden during 1992-1995, the safety of DAPTACEL vaccine was compared with DT and a whole-cell pertussis DTP vaccine. A standard diary card was kept for 14 days after each dose and follow-up telephone calls were made 1 and 14 days after each injection. Telephone calls were made monthly to monitor the occurrence of severe events and/or hospitalizations for the 2 months after the last injection (FDA: DAPTACEL).
Immune Response: One clinical study found that among a random subset of children who received the fourth dose of DAPTACEL vaccine at 15-16 months of age, 96.5% achieved diphtheria antitoxin levels of ≥1.0 IU/mL after the fourth dose (FDA: DAPTACEL).
Side Effects: Side effects of vaccination are: injection site reactions, irritability, fussiness, and lethargy.

7. DECAVAC

a. Product Name:

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use

b. Tradename:

DECAVAC

c. Manufacturer:

Sanofi Pasteur, Inc

d. Vaccine Ontology ID:

VO_0000030

e. CDC CVX code:

113

f. Type:

Toxoid vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1725)

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0001240
Description: It is for intramuscular injection, and is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution (Decavac).

k. Preparation

The cultures are grown in a modified Mueller and Miller medium. Diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum. (FDA: Decavac).

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store at 2° to 8°C (35° to 46°F). Do not freeze. Do not use vaccine after expiration date.

n . Approved Age for Licensed Use

DECAVAC vaccine is indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older (FDA: Decavac).

o. Contraindication

Do not use after anaphylaxis or other serious allergic reaction following a previous dose of this vaccine, any other tetanus or diphtheria toxoid containing vaccine, or any component of this vaccine

p. Description

It is for intramuscular injection, and is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution (FDA: Decavac).

q. Human Response

Vaccination Protocol: A clinical study involving 58 individuals 6-58 years of age (FDA: Decavac).
Side Effects: Side effects include: erythema, tenderness and induration at the injection site and 2% systemic reactions consisting of headache, malaise and temperature elevations. Boosters can accentuate side effects(FDA: Decavac)
Efficacy: The results that indicated protective levels of antibody were achieved in greater than 90% of the study population after primary immunization with both components. Booster effects were achieved in 100% of the individuals with pre-existing antibody responses (FDA: Decavac).

8. Diphtheria and Tetanus Toxoids Adsorbed

a. Product Name:

Diphtheria and Tetanus Toxoids Adsorbed

b. Tradename:

None

c. Manufacturer:

Sanofi Pasteur Inc

d. Vaccine Ontology ID:

VO_0000033

e. CDC CVX code:

f. Type:

Inactivated or "killed" vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1725), Canada

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0001240

k. Preparation

The vaccine is grown in a peptone-based medium containing bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.

n . Approved Age for Licensed Use

6 weeks to 6 years of age

o. Contraindication

Hypersensitivity to any component of the vaccine, including thimerosal, a mercury derivative, is a contraindication for further use of this vaccine. It is a contraindication to use this or any other related vaccine after an immediate anaphylactic reaction associated with a previous dose (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).

p. Description

The primary series of vaccination for infants 6 weeks through 12 months, consists of 4 doses: administer three 0.5 mL doses intramuscularly 4 to 8 weeks apart. A reinforcing dose is given 6 to 12 months after the third injection (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).

q. Human Response

Vaccination Protocol: A clinical study was performed in 20 children under one year of age to determine the serological responses and the adverse reactions (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
Immune Response: Protective levels of diphtheria antitoxins were detected in 100% of the children following two doses of the vaccine (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
Side Effects: With vaccination, there are little to no adverse reactions to the vaccine. The most widely reported side effects were injection site reactions (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
Efficacy: A complete vaccination series substantially reduces the risk of developing diphtheria, and vaccinated persons who develop disease have milder illness. Protection lasts at least 10 years. Vaccination does not, however, eliminate carriage of C. diphtheriae in the pharynx or nose or on the skin (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).

9. DT Polio Adsorbed

a. Tradename:

DT Polio Adsorbed

b. Manufacturer:

Sanofi Pasteur Ltd

c. Vaccine Ontology ID:

VO_0010709

d. Type:

Subunit vaccine + Inactivated or "killed" vaccine

e. Status:

Licensed

f. Location Licensed:

Canada

g. Host Species for Licensed Use:

Human

h. Adjuvant:

VO ID: VO_0000128
Description: Products: Proteins + killed virus. Other components: Formaldehyde.

i. Preservative:

2 phenoxy ethanol

j. Allergen:

Polymyxin B Neomycin

k. Immunization Route

Intramuscular injection (i.m.)

l . Approved Age for Licensed Use

Ages 7 and older.

m. Description

Products: Proteins + killed virus. Other components: Formaldehyde.

10. Infanrix

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

b. Tradename:

Infanrix

c. Manufacturer:

GlaxoSmithKline Biologicals

d. Vaccine Ontology ID:

VO_0000064

e. CDC CVX code:

f. Type:

Inactivated or "killed" vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1617)

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0000127
Description: INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age. INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: INFANRIX).

k. Preparation

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract.

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store INFANRIX refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.

n . Approved Age for Licensed Use

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday). Because of the substantial risks of complications from pertussis disease in infants, completion of the primary series of 3 doses of vaccine early in life is strongly recommended. INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older. When passive protection against tetanus or diphtheria is required, Tetanus Immune Globulin or Diphtheria Antitoxin, respectively, should be administered at separate sites (FDA: INFANRIX).

o. Contraindication

Hypersensitivity to any component of the vaccine and ti should not be administered to anyone with a known previous allergic reaction associated with the vaccine (FDA: INFANRIX).

p. Description

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age. INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: INFANRIX).

q. Human Response

Vaccination Protocol: Efficacy of diphtheria toxoid used in INFANRIX was determined on the basis of immunogenicity studies (FDA: INFANRIX).
Side Effects: Side effects of vaccination include: injection site reactions, fever, irritability, drowsiness, loss of appetite, and vomiting (FDA: INFANRIX).
Efficacy: A VERO cell toxin neutralizing test confirmed the ability of infant sera, obtained 1 month after a 3-dose primary series, to neutralize diphtheria toxin. Levels of diphtheria antitoxin were achieved in 100% of the sera tested (FDA: INFANRIX).

11. Infanrix -IPV/Hib

a. Tradename:

Infanrix -IPV/Hib

b. Manufacturer:

GlaxoSmithKline

c. Vaccine Ontology ID:

VO_0010722

d. CDC CVX code:

120

e. Type:

Subunit vaccine + Inactivated or "killed" vaccine

f. Status:

Licensed

g. Location Licensed:

Canada

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000127

j. Preservative:

2 phenoxy ethanol

k. Allergen:

Polymyxin B Neomycin , Latex in plunger stopper of prefilled syringe

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store in a refrigerator (2°C – 8°C).

n . Approved Age for Licensed Use

2 months to 6 years of age.

o. Description

Products: Proteins + killed virus + conjugate. Other components: Formaldehyde Polysorbate 80, Lactose.

12. Infanrix-hexa

a. Product Name:

Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine

b. Tradename:

Infanrix-hexa

c. Manufacturer:

GlaxoSmithKline

d. Vaccine Ontology ID:

VO_0010719

e. Type:

Subunit vaccine + Inactivated or "killed" vaccine

f. Status:

Licensed

g. Location Licensed:

Canada

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000127

j. Adjuvant:

VO ID: VO_0000128

k. Preservative:

2 phenoxy ethanol

l. Allergen:

Polymyxin B Neomycin, Latex in plunger stopper of prefilled syringe

m. Immunization Route

Intramuscular injection (i.m.)

n. Storage

Should be stored at 2° to 8°C (35° to 46°F).

o . Approved Age for Licensed Use

Under 7 years of age

p. Description

Products: Proteins + killed viruses + conjugate. Other components: Yeast protein Formaldehyde, Lactose, Polysorbate 20 and 80.

13. Infanrix-IPV

a. Tradename:

Infanrix-IPV

b. Manufacturer:

GlaxoSmithKline

c. Vaccine Ontology ID:

VO_0010721

d. Type:

Subunit vaccine + Inactivated or "killed" vaccine

e. Status:

Licensed

f. Location Licensed:

Canada

g. Host Species for Licensed Use:

Human

h. Adjuvant:

VO ID: VO_0000127

i. Preservative:

2 phenoxy ethanol

j. Allergen:

Polymyxin B Neomycin , Latex in plunger stopper of prefilled syringes

k. Immunization Route

Intramuscular injection (i.m.)

l. Storage

Store in a refrigerator (2°C - 8°C).

m . Approved Age for Licensed Use

2 months to 6 years of age.

n. Description

Products: Proteins + killed virus. Other components: Formaldehyde, Polysorbate 80.

14. Infanrix/Hib

a. Tradename:

Infanrix/Hib

b. Manufacturer:

GlaxoSmithKline

c. Vaccine Ontology ID:

VO_0010720

d. Type:

Subunit vaccine + Inactivated or "killed" vaccine

e. Status:

Licensed

f. Location Licensed:

Canada

g. Host Species for Licensed Use:

Human

h. Adjuvant:

VO ID: VO_0000127
Description: Products: Proteins + conjugate. Other components: Formaldehyde, Lactose.

i. Preservative:

2 phenoxy ethanol

j. Allergen:

Latex in plunger stopper of prefilled syringe

k. Immunization Route

Intramuscular injection (i.m.)

l. Storage

Store at 2°C – 8°C (in a refrigerator).

m . Approved Age for Licensed Use

15 months and older

n. Description

Products: Proteins + conjugate. Other components: Formaldehyde, Lactose.

15. KINRIX

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine

b. Tradename:

KINRIX

c. Manufacturer:

GlaxoSmithKline Biologicals

d. Vaccine Ontology ID:

VO_0000067

e. CDC CVX code:

130

f. Type:

Inactivated or "killed" vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1617)

i. Host Species for Licensed Use:

Human

j. Antigen

Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussin toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) (FDA: KINRIX).

The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX.

k. Adjuvant:

VO ID: VO_0000127
Description: A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose (FDA: KINRIX).

l. Preparation

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. After, they are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA: KINRIX).

m. Immunization Route

Intramuscular injection (i.m.)

n. Storage

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.

o . Approved Age for Licensed Use

A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose (FDA: KINRIX).

p. Contraindication

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis or poliovirus-containing vaccine, or to any component of KINRIX, including neomycin and polymyxin B, encephalopathy within 7 days of administration of a previous pertussis-containing vaccine and progressive neurologic disorders (FDA: KINRIX).

q. Description

r. Human Response

Vaccination Protocol: The primary study (Study 048), conducted in the United States, was a randomized, controlled clinical trial in which children 4 to 6 years of age were vaccinated with KINRIX (N = 3,156) or control vaccines (INFANRIX and IPOL® vaccine [IPV, Sanofi Pasteur SA]; N = 1,053) as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth IPV dose following 3 doses of IPOL (FDA: KINRIX).
Immune Response: After vaccination, antibody levels in clinical trials was determined to be between 85-100% for all subjects (FDA: KINRIX).
Side Effects: The most common side effects reported were: injection site reactions, fever, drowisness, and loss of appetite (FDA: KINRIX).

16. Pediacel

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein – Conjugate)

b. Tradename:

Pediacel

c. Manufacturer:

Sanofi Pasteur Ltd

d. Vaccine Ontology ID:

VO_0010730

e. Type:

Subunit vaccine + Inactivated or "killed" vaccine

f. Status:

Licensed

g. Location Licensed:

Canada

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000128
Description: Products: Proteins, killed virus + conjugate. Other components: Bovine serum Formaldehyde, Polysorbate 80.

j. Preservative:

2 phenoxy ethanol

k. Allergen:

Neomycin Polymyxin B Streptomycin, Latex in stopper of vial

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store at 2° to 8°C (35° to 46°F).

n . Approved Age for Licensed Use

2 months to 6 years of age.

o. Description

Products: Proteins, killed virus + conjugate. Other components: Bovine serum Formaldehyde, Polysorbate 80.

17. Pediarix

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined

b. Tradename:

Pediarix

c. Manufacturer:

GlaxoSmithKline Biologicals

d. Vaccine Ontology ID:

VO_0000082

e. CDC CVX code:

110

f. Type:

Inactivated or "killed" vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1617)

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0000127
Description: It contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).

k. Allergen:

yeast, neomycin,polymyxin B

l. Preparation

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The diphtheria, tetanus, and pertussis antigens are individually adsorbed onto aluminum hydroxide then diluted and combined to produce the final formulated vaccine (FDA: Pediarix).

m. Immunization Route

Intramuscular injection (i.m.)

n. Storage

The vaccine should be refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.

o . Approved Age for Licensed Use

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age. PEDIARIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: Pediarix).

p. Contraindication

Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, the vaccine should also not be administered to anyone with a previous allergic reaction to a dose of the vaccine (FDA: Pediarix).

q. Description

It contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).

r. Human Response

Vaccination Protocol: A double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy, sponsored by the National Institutes of Health (NIH), assessed the absolute protective efficacy of INFANRIX when administered at 2, 4, and 6 months of age (FDA: Pediarix).
Immune Response: In response to vaccination, all patients seem to have around 90-100% antibody response.
Side Effects: The most reported side effects included: injection site reactions, fever, drowsiness, loss of appetite and fussiness (FDA: Pediarix).

18. Pentacel

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine

b. Tradename:

Pentacel

c. Manufacturer:

Sanofi Pasteur Limited

d. Vaccine Ontology ID:

VO_0000084

e. CDC CVX code:

120

f. Type:

Subunit vaccine + Inactivated or "killed" vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1726), Canada

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0000128
Description: It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b (FDA: Pentacel).

k. Preservative:

2 phenoxy ethanol

l. Allergen:

Polymyxin B, Neomycin

m. Preparation

Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. (FDA: Pentacel).

n. Immunization Route

Intramuscular injection (i.m.)

o. Storage

Store at 2° to 8°C (35° to 46°F). Do not freeze.

p . Approved Age for Licensed Use

6 weeks to 4 years of age.

q. Contraindication

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Pentacel vaccine, any ingredient of this vaccine, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine or H influenzae type b vaccine is a contraindication. (FDA: Pentacel).

r. Description

It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b (FDA: Pentacel).

s. Human Response

Vaccination Protocol: A clinical study looked at anti-PRP seroprotection rates and GMCs one month following Dose 3 of Pentacel vaccine or separately administered ActHIB vaccine in studies P3T06 and M5A10 (FDA: Pentacel).
Immune Response: After vaccination, subjects achieved 90% or greater anti-PRP ≥0.15 μg/mL (FDA: Pentacel).
Side Effects: Injection site reactions include: Redness, swelling, tenderness, and an increase in arm circumference. The Systemic reactions include: fever, decreased activity, inconsolable crying, and irritability. (FDA: Pentacel).

19. Quadracel

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

b. Tradename:

Quadracel

c. Manufacturer:

Sanofi Pasteur Ltd

d. Vaccine Ontology ID:

VO_0010736

e. Type:

Subunit vaccine + Inactivated or "killed" vaccine

f. Status:

Licensed

g. Location Licensed:

Canada

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000128
Description: Description: Products: Proteins + killed virus. Other components: Bovine albumin Formaldehyde, Glutaraldehyde, Polysorbate 80.

j. Preservative:

2 phenoxy ethanol

k. Allergen:

Polymyxin B, Neomycin

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store at 2 to 8C (35 to 46F). Do not freeze.

n . Approved Age for Licensed Use

2 months to six years of age.

o. Description

Products: Proteins + killed virus. Other components: Bovine albumin Formaldehyde, Glutaraldehyde, Polysorbate 80.

20. Td Adsorbed

a. Product Name:

Tetanus and Diphtheria Toxoids Adsorbed

b. Tradename:

Td Adsorbed

c. Manufacturer:

Sanofi Pasteur Ltd

d. Vaccine Ontology ID:

VO_0010739

e. Type:

Toxoid vaccine

f. Status:

Licensed

g. Location Licensed:

Canada

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000128
Description: Td ADSORBED is a sterile, cloudy, uniform suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate asuspended in isotonic sodium chloride solution for intramuscular injection only.

j. Immunization Route

Intramuscular injection (i.m.)

k. Storage

Store at 2º to 8ºC (35º to 46ºF).

l . Approved Age for Licensed Use

7 Years and Older

m. Description

Td ADSORBED is a sterile, cloudy, uniform suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate asuspended in isotonic sodium chloride solution for intramuscular injection only.

21. Td Polio Adsorbed

a. Tradename:

Td Polio Adsorbed

b. Manufacturer:

Sanofi Pasteur Ltd

c. Vaccine Ontology ID:

VO_0011482

d. Type:

Subunit vaccine + Inactivated or "killed" vaccine

e. Status:

Licensed

f. Location Licensed:

Canada

g. Host Species for Licensed Use:

Human

h. Adjuvant:

VO ID: VO_0000128
Description: Td POLIO ADSORBED [Tetanus and Diphtheria Toxoids Adsorbed and Inactivated Poliomyelitis Vaccine]
produced by Sanofi Pasteur Limited, is a sterile, cloudy, white, uniform suspension of tetanus and diphtheria
toxoids adsorbed on aluminum phosphate and suspended in phosphate buffered saline solution and
combined with Inactivated Poliomyelitis Vaccine for intramuscular injection only.
Products: Proteins + killed virus. Other components: Bovine albumin Formaldehyde, Polysorbate 80.

i. Preservative:

2 phenoxy ethanol

j. Allergen:

Polymyxin B Neomycin

k. Immunization Route

Intramuscular injection (i.m.)

l. Storage

Store at 2° to 8°C (35° to 46°F).

m . Approved Age for Licensed Use

7 years and older.

n. Description

Td POLIO ADSORBED [Tetanus and Diphtheria Toxoids Adsorbed and Inactivated Poliomyelitis Vaccine] produced by Sanofi Pasteur Limited, is a sterile, cloudy, white, uniform suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate and suspended in phosphate buffered saline solution and combined with Inactivated Poliomyelitis Vaccine for intramuscular injection only. Products: Proteins + killed virus. Other components: Bovine albumin Formaldehyde, Polysorbate.

22. TENIVAC

a. Product Name:

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use

b. Tradename:

TENIVAC

c. Manufacturer:

Sanofi Pasteur, Ltd

d. Vaccine Ontology ID:

VO_0000102

e. Type:

Toxoid vaccine

f. Status:

Licensed

g. Location Licensed:

USA (License #1726)

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000128
Description: Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (Tenivac).

j. Preparation

Corynebacterium diphtheriae is grown in modified Mueller’s 223 growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is 224 detoxified with formaldehyde and diafiltered.(Tenivac)

k. Immunization Route

Intramuscular injection (i.m.)

l. Storage

TENIVAC vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.

m . Approved Age for Licensed Use

TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (Tenivac).

n. Contraindication

Severe allergic reaction (e.g., anaphylaxis) to a previous dose of TENIVAC, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication.(Tenivac)

o. Description

Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.(Tenivac)

p. Human Response

Vaccination Protocol: A clinical study evaluated 17 participants ages 6 to 56 years conducted in Canada (Tenivac).
Immune Response: Four weeks following the second dose, all 17 participants had a serum diphtheria antitoxin level ≥0.01 IU/mL. Four weeks following the third dose, all 17 participants had a serum diphtheria antitoxin level >0.1 IU/mL (Tenivac).
Side Effects: The most frequent solicited injection site reaction within 0-3 days following TENIVAC was pain, reported in 78.3% of study participants 11-59 years of age and 35.3% of participants ≥60 years of age. Contraindicatons include pain, redness, swelling, and systemic adverse effects (Tenivac).

23. Tetanus and Diphtheria Toxoids Adsorbed

a. Product Name:

Tetanus and Diphtheria Toxoids, Adsorbed

b. Tradename:

None

c. Manufacturer:

MassBiologics

d. Type:

Toxoid vaccine

e. Status:

Licensed

f. Location Licensed:

USA

g. Host Species for Licensed Use:

Human

h. Immunization Route

Intramuscular injection (i.m.)

i. Storage

Store at 2°C - 8°C (36°F - 46°F), do not freeze.

j . Approved Age for Licensed Use

7 years of age and older.

k. Description

Tetanus and Diphtheria Toxoids Adsorbed (Td) manufactured by MassBiologics is a sterile vaccine for intramuscular injection. After shaking, the vaccine appears as a homogeneous milky white suspension. Each 0.5 ml dose of MassBiologics’ Td is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Each 0.5 ml dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde, and a trace amount of thimerosal [mercury derivative, (< 0.3 mcg mercury/dose)] (not as a preservative) from the manufacturing process. (FDA: Tetanus and Diphtheria Toxoids Adsorbed)

24. Tripacel

a. Product Name:

Pertussis Vaccine-Acellular, Combined with Diphtheria and Tetanus Toxoids (Adsorbed)

b. Tradename:

Tripacel

c. Manufacturer:

Sanofi Pasteur Ltd

d. Vaccine Ontology ID:

VO_0010742

e. Type:

Subunit vaccine

f. Status:

Licensed

g. Location Licensed:

Canada

h. Host Species for Licensed Use:

Human

i. Adjuvant:

VO ID: VO_0000128
Description: Products: Proteins. Other components: Formaldehyde, Glutaraldehyde.

j. Preservative:

2 phenoxy ethanol

k. Allergen:

Latex in stopper

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store at 2° to 8°C.

n . Approved Age for Licensed Use

2 months to 8 years

o. Description

Products: Proteins. Other components: Formaldehyde, Glutaraldehyde.

25. Tripedia

a. Product Name:

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

b. Tradename:

Tripedia

c. Manufacturer:

Sanofi Pasteur, Inc.

d. Vaccine Ontology ID:

VO_0000112

e. CDC CVX code:

f. Type:

Toxoid vaccine

g. Status:

Licensed

h. Location Licensed:

USA (License #1725)

i. Host Species for Licensed Use:

Human

j. Adjuvant:

VO ID: VO_0001240
Description: Tripedia vaccine combines diptheria and tetanus toxoids with purified pertussis antigens. It consists of 3 doses administered at intervals of 4-8 weeks (FDA: Tripedia).

k. Preparation

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium. It is detoxified with formaldehyde and then seperately purified by serial ammonium sulfate fractionation and diafiltration (FDA: Tripedia).

l. Immunization Route

Intramuscular injection (i.m.)

m. Storage

Store between 2 and 8 degrees Celsius. DO NOT FREEZE.

n . Approved Age for Licensed Use

Tripedia vaccine is indicated for active immunization against diphtheria, tetanus, and pertussis simultaneously in infants and children 6 weeks to 7 years of age (prior to seventh birthday) (FDA: Tripedia).

o. Contraindication

This vaccine should not be administered to anyone with a known hypersensitivity to any component of the vaccine.

p. Description

Tripedia vaccine combines diptheria and tetanus toxoids with purified pertussis antigens. It consists of 3 doses administered at intervals of 4-8 weeks (FDA: Tripedia).

q. Human Response

Side Effects: Side effects of vaccination include: injection site reactions, fevver, irritability, drowsiness, and vomiting. In some cases with infant immunization, anorexia and an unusual hig-pitched cry were reported (FDA: Tripedia).
Efficacy: Complete immunization significantly reduces the risk of developing diptheria and protection lasts around 10 years.

IV. References

1. Adacel: Adacel [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172481.htm]

2. Boostrix: Boostrix [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172925.htm]

3. CDC: Diphtheria: CDC: Diphtheria general information [http://www.cdc.gov/ncidod/dbmd/diseaseinfo/diptheria_t.htm]

4. FDA: DAPTACEL: FDA: DAPTACEL Vaccine [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101572.htm]

5. FDA: Decavac: Decavac [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094067.htm]

6. FDA: Diphtheria and Tetanus Toxoids Adsorbed: FDA: Diphtheria and Tetanus Toxoids Adsorbed [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142732.pdf]

7. FDA: INFANRIX: FDA: INFANRIX [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101568.htm]

8. FDA: KINRIX: FDA: KINRIX Vaccine [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM241453.pdf]

9. FDA: Menactra: FDA: Menactra Vaccine [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm176044.htm]

10. FDA: Pediarix: FDA: Pediarix [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm146759.htm]

11. FDA: Pentacel: FDA: Pentacel Vaccine [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109810.pdf]

12. FDA: Quadracel: FDA: Quadracel vaccine information [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM439903.pdf]

13. FDA: TENIVAC: FDA: TENIVAC vaccine information [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM152826.pdf]

14. FDA: Tetanus and Diphtheria Toxoids Adsorbed: FDA: Tetanus and Diphtheria Toxoids Adsorbed vaccine information [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM164127.pdf]

15. FDA: Tripedia: FDA: Tripedia [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101565.htm]

16. GSK: Boostrix-Polio: GSK:Boostrix-Polio vaccine information [https://ca.gsk.com/media/589683/boostrix-polio.pdf]

17. GSK: Infanrix-hexa: GSK: Infanrix-hexa vaccine information [http://ca.gsk.com/media/537989/infanrix-hexa.pdf]

18. GSK: Infanrix-IPV: GSK: Infanrix-IPV vaccine information [http://ca.gsk.com/media/590851/infanrix-ipv.pdf]

19. GSK: Infanrix-IPV/Hib: GSK: Infanrix-IPV/Hib vaccine information [http://ca.gsk.com/media/590970/infanrix-ipv-hib.pdf]

20. Holmes, 2000: Holmes RK. Biology and molecular epidemiology of diphtheria toxin and the tox gene. The Journal of infectious diseases. 2000; 181 Suppl 1; S156-167. [PubMed: 10657208].

21. Khrustaleva et al., 2015: Khrustaleva TA, Khrustalev VV, Barkovsky EV, Kolodkina VL, Astapov AA. Structural and antigenic features of the synthetic SF23 peptide corresponding to the receptor binding fragment of diphtheria toxin. Molecular immunology. 2015; 63(2); 235-244. [PubMed: 25062832].

22. MicrobeWiki: C. diphtheriae: MicrobeWiki: C. diphtheriae [http://microbewiki.kenyon.edu/index.php/Corynebacterium_diphtheriae]

23. Product Monograph: Adacel-Polio: Product Monograph: Adacel-Polio vaccine information [https://www.vaccineshoppecanada.com/document.cfm?file=adacel-polio_e.pdf]

24. Product Monograph: Pediacel: Product Monograph: Pediacel vaccine information [https://www.vaccineshoppecanada.com/document.cfm?file=Pediacel_E.pdf]

25. Product Monograph: Td Adsorbed: Product Monograph: Td Adsorbed vaccine information [https://www.vaccineshoppecanada.com/document.cfm?file=td_adsorbed_e.pdf]

26. Product Monograph: Td Polio Adsorbed: Product Monograph: Td Polio Adsorbed vaccine information [https://www.vaccineshoppecanada.com/document.cfm?file=td_polio_adsorbed_e.pdf]

27. Textbook of Bacteriology: Diphtheria [http://textbookofbacteriology.net/diphtheria]