• Product Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
• Tradename: Adacel
• Manufacturer: Sanofi Pasteur, Ltd (USA: License #1726)
• Vaccine Ontology ID: VO_0000005
• CDC CVX code: 20, 115
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA: License #1726
• Host Species for Licensed Use: Human
• Antigen: Pertussis
• 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.(FDA: Adacel)
• Preparation: Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.(FDA: Adacel)
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE
• 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.
• 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. (FDA: Adacel)
• Description: It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.(FDA: Adacel)

• Product Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
• Tradename: Boostrix
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000015
• CDC CVX code: 20, 115
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1617)
• Host Species for Licensed Use: Human
• 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 (FDA Boostrix).
• Preparation: Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. Toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA Boostrix).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
• Approved Age for Licensed Use: BOOSTRIX is approved for use in individuals 10 through 64 years of age (FDA Boostrix).
• 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 (FDA Boostrix).
• 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 (FDA Boostrix).

• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
• Tradename: DAPTACEL
• Manufacturer: Sanofi Pasteur, Ltd.
• Vaccine Ontology ID: VO_0000029
• CDC CVX code: 20, 106
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1726)
• Host Species for Licensed Use: Human
• Antigen: Isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids (FDA: DAPTACEL).
• Adjuvant:
  • VO ID: VO_0000128
• Preparation: Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration (FDA: DAPTACEL).
• Storage: should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
• 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).
• 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).
• 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.

• Product Name: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
• Tradename: Decavac
• Manufacturer: Sanofi Pasteur, Inc
• Vaccine Ontology ID: VO_0000030
• CDC CVX code: 113
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1725)
• Host Species for Licensed Use: Human
• Adjuvant:
  • VO ID: VO_0000193
  • 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).
• Preparation: Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The toxins are 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).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store at 2° to 8°C (35° to 46°F). Do not freeze. Do not use vaccine after expiration date.
• 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).
• 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 (FDA Decavac).
• 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).

• Product Name: Diphtheria and Tetanus Toxoids Adsorbed
• Tradename: No Tradename
• Manufacturer: Sanofi Pasteur Inc
• Vaccine Ontology ID: VO_0000033
• CDC CVX code: 28
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (FDA License #1725), Canada
• Host Species for Licensed Use: Human
• Antigen: Detoxified toxins from Corynebacterium diphtheriae and Clostridium tetani (FDA: dttadLB)
• Adjuvant:
  • VO ID: VO_0001240
  • Description: This vaccine is for intramuscular use. It is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution (FDA: dttadLB).
• Preparation: Clostridium tetani cultures are grown in a peptone-based medium containing bovine extract. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
• Approved Age for Licensed Use: Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT) is indicated for active immunization of children up to age 7 years against diphtheria and tetanus. Immunization should be started at 6 weeks to 2 months of age and be completed before the seventh birthday. Immunization always should be started at once if diphtheria is present in the community. This vaccine should NOT be used for immunizing persons 7 years of age and older. For persons 7 years of age and older, the recommended vaccine is Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) (FDA: Tetanus Toxoid Adsorbed by Sanofi Pasteur Inc).
• Contraindication: Hypersensitivity to any component of the vaccine is a contraindication, use of related vaccine after an immediate anaphylactic reaction associated with a previous dose, and history of systemic allergic or neurologic reactions following a previous dose (FDA: dttadLB).
• Description: This vaccine is for intramuscular use. It is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution (FDA: dttadLB).

• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
• Tradename: Infanrix
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000064
• CDC CVX code: 20
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1617 ), Canada
• Host Species for Licensed Use: Human
• Antigen: Diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] (FDA Infanrix).
• Adjuvant:
  • VO ID: VO_0000127
  • Description: The vaccine is an noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide (FDA Infanrix).
• Preparation: Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA Infanrix).
• Storage: Store INFANRIX refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
• 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). 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).
• Contraindication: Hypersensitivity to any component of the vaccine is a contraindication, the vaccine should not be administered to anyone with encephalopathy, progressive neurological disorders, or an allergic reaction to a previous dose (FDA Infanrix).
• Description: The vaccine is an noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide (FDA Infanrix).

• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
• Tradename: KINRIX
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000067
• CDC CVX code: 130
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1617)
• Host Species for Licensed Use: Human
• 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 (FDA: KINRIX).
• Adjuvant:
  • VO ID: VO_0000127
• Preparation: Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is then detoxified with formaldehyde, concentrated by ultrafiltration, and purified by recipitation, dialysis, and sterile filtration (FDA: KINRIX).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
• 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).
• Contraindication: 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/or progressive neurologic disorders (FDA: KINRIX).

• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
• Tradename: Pediarix
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000082
• CDC CVX code: 110
• Type: Subunit vaccine + Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1617)
• Host Species for Licensed Use: Human
• Adjuvant:
  • VO ID: VO_0000127
  • Description: The vaccine 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).
• Allergen: Polymyxin B Neomycin, Latex in plunger stopper of prefilled syringe
• Preparation: Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is then detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA: Pediarix).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store PEDIARIX refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
• 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).
• Contraindication: Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, is a contraindication. The vaccine should not be administered to anyone with a previous alergic reaction following a dose of the vaccine, or if they have encephalopathy or a progressive neurologic disorder (FDA: Pediarix).
• Description: The vaccine 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).

• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
• Tradename: Pentacel
• Manufacturer: Sanofi Pasteur Limited
• Vaccine Ontology ID: VO_0000084
• CDC CVX code: 120
• Type: Subunit vaccine + Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1726), Canada
• Host Species for Licensed Use: Human
• 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. Pentacel vaccine is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday) (FDA: Pentacel).
• Preservative: 2 phenoxy ethanol
• Allergen: Polymyxin B, Neomycin
• Preparation: Clostridium tetani is grown in modified Mueller-Miller casamino acid medium. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate (FDA: Pentacel).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store at 2° to 8°C (35° to 46°F). Do not freeze
• Approved Age for Licensed Use: Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday) (FDA: Pentacel).
• 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. The vaccine should also not be administered to anyone with known encephalopathy or a progressive neurologic disorder (FDA: Pentacel).
• 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. Pentacel vaccine is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday) (FDA: Pentacel).

• Product Name: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
• Tradename: TENIVAC
• Manufacturer: Sanofi Pasteur, Ltd
• Vaccine Ontology ID: VO_0000102
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1726)
• Host Species for Licensed Use: Human
• Adjuvant:
  • VO ID: VO_0000128
  • Description: TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (FDA: Tenivac).
• Preparation: Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. (FDA: Tenivac)
• Immunization Route: Intramuscular injection (i.m.)
• Storage: TENIVAC vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
• 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 (FDA: Tenivac).
• 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.(FDA: Tenivac)
• Description: Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older(FDA: Tenivac)

• Product Name: Tetanus Toxoid Adsorbed
• Tradename: None
• Manufacturer: Sanofi Pasteur, Inc.
• Vaccine Ontology ID: VO_0000033
• CDC CVX code: 28
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1725)
• Adjuvant:
  • VO ID: VO_0000128
• Preparation: C. tetani culture is grown in a peptone-based medium containing an extract of bovine muscle tissue and detoxified with formaldehyde. The detoxified material is purified by serial ammonium sulfate fractionation and diafiltration, followed by sterile filtration. The toxoid is adsorbed to aluminum potassium sulfate (alum). The adsorbed toxoid is diluted with physiological saline solution (0.85%) (FDA: Tetanus Toxoid Adsorbed by Sanofi Pasteur Inc).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store between 2° – 8°C (35° – 46°F). DO NOT FREEZE.
• Contraindication: This vaccine should not be administered to anyone with a known hypersensitivity to any component of the vaccine, including thimerosal (FDA: Tetanus Toxoid Adsorbed by Sanofi Pasteur Inc)
• Description: Tetanus Toxoid Adsorbed manufactured by Aventis Pasteur Inc., for intramuscular injection, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution (FDA: Tetanus Toxoid Adsorbed).

• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
• Tradename: Tripedia
• Manufacturer: Sanofi Pasteur, Inc.
• Vaccine Ontology ID: VO_0000112
• CDC CVX code: 20
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (FDA License #1725)
• Host Species for Licensed Use: Human
• 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)
• Preparation: Clostridium tetani cultures are grown in a peptone-based medium containing a bovine extract. It is then detoxified with formaldehyde and seperately purified by serial ammonium sulfate fractionation and diafiltration.(FDA: Tripedia)
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store between 2 and 8 degrees Celsius. DO NOT FREEZE.
• 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). Due to substantial risks of complications of the disease, completion of a primary series of pertussis vaccine early in life is strongly recommended (FDA: Tripedia).
• Contraindication: This vaccine should not be administered to anyone with a known hypersensitivity to any component of the vaccine.
• 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)

Human Response

• Vaccination Protocol: The use of Adacel vaccine as a primary series, or to complete the primary series, has not been studied. Vaccination with Adacel vaccine may not protect all of vaccinated individuals (FDA: Adacel).
• Immune Response: Strong antibody response was induced after the first immunization. The antibody response after booster immunization was also strong, esp. for young age group. The Adacel-induced immune response levels after the first immunization and booster immunization were comparable to those induced by a US licensed Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine manufactured by Sanofi Pasteur Inc., Swiftwater, PA (FDA: 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.(FDA: Adacel)

Human Response

• Vaccination Protocol: BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose.
• Immune Response: In Boostrix, N=1440 to 1444, pre-vaccination levels in a 95% confidence interval were 85.2, while post-vaccination levels at a 95% confidence interval were 98.2 (FDA 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 (FDA Boostrix).

Human Response

• 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: The most common side effects reported are: injection site reactions, fussiness/irritability, inconsolable crying, and decreased activity/lethargy, and fever (FDA: DAPTACEL).
• Efficacy: A tetanus antitoxin level ≥0.1 IU/mL as measured by the ELISA used in clinical studies of DAPTACEL vaccine is considered protective (FDA: DAPTACEL).

Human Response

• 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).

Human Response

• Immune Response: In one clinical trial, protective levels of diphtheria and tetanus antitoxins were detected in 100% of the children following two doses of the vaccine (FDA: dttadLB).
• Side Effects: Adverse reactions may be local and include redness, warmth, edema, induration, with or without tenderness, as well as urticaria, and rash. Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop as well (FDA: dttadLB).
• 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: dttadLB).

Human Response

• Immune Response: Ninety percent of infants who received Hib simultaneously with INFANRIX achieved anti-PRP antibodies >1 mcg/mL (N = 72), and 96% to 100% of infants who received OPV simultaneously with INFANRIX showed protective neutralizing antibody to poliovirus Types 1, 2, and 3 (N = 60-61) (FDA Infanrix).
• Side Effects: Injection site reactions, irritability, drowsiness, loss of appetite, vomiting, and crying (FDA Infanrix).

Human Response

• 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 are: local injection site reactions, drowsiness, fever and loss of appetite (FDA: KINRIX).

Human Response

• Immune Response: In response to vaccination, all patients seem to have around 90-100% antibody response.
• Side Effects: Most common side effects reported are: local injection site reactions, fever, fussiness/irritability, and loss of appetite.
• Efficacy: Following immunization, protection persists for at least 10 years.

Human Response

• Immune Response: There was no evidence for interference in the immune response to the fourth dose of PCV7 (percent of participants with antibody levels ≥0.15 μg/mL and ≥0.5 μg/mL and GMCs to each serotype) administered at 15 months of age concomitantly with Pentacel vaccine (N = 155) (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).

Human Response

• Immune Response: Among adults 65 years of age and over who received TENIVAC vaccine (N = 419), 94.5% (95% 273 confidence interval 91.9, 96.5) had a post-vaccination diphtheria antitoxoid level 275 ≥0.1 IU/mL (FDA: 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(FDA: Tenivac)

Human Response

• Side Effects: Side effects of vaccination are: injection site reactions, fever, and nausea.

Human Response

• Immune Response: Overall seroconversion rates in chuldren who received ActHIB reconstituted with Tripedia vaccine were 98%, 98%, and 96% for measles, mumps, and rubella, respectively.(FDA: Tripedia)
• 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 is said to last around 10 years.(FDA: Tripedia)