Corynebacterium diphtheriae 1717 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). Diphtheria 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). 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). 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). Baboon Papio cynocephalus 9556 Bank vole Clethrionomys glareolus 447135 Bear Ursus americanus 9643 Birds Passeroidea 175121 Brown Trout Salmo trutta 8032 Buffalo Bison bison 9901 Carnivores Vulpes 9625 Cat Felis catus 9685 Catfishes Siluriformes 7995 Cattle Bos taurus 9913 Chicken Gallus gallus 9031 Chimpanzee Pan troglodytes 9598 chinchillas Chinchillidae 10150 Copper Pheasant Syrmaticus soemmerringii 9067 Deer Cervus elaphus 9860 Deer mouse Peromyscus maniculatus 10042 Dog Canis familiaris 9615 Ducks Anas 8835 Ferret Mustela putorius furo 9669 Fish Hyperotreti 117565 Gerbil Gerbillina 10045 Goat Capra hircus 9925 Gray wolf Canis lupus 9612 Guinea pig Cavia porcellus 10141 Hamster Mesocricetus auratus 10036 Horse Equus caballus 9796 Human Homo sapiens 9606 Macaque Macaca fascicularis 9541 Mongolian Gerbil Meriones unguiculatus 10047 Monkey Platyrrhini 9479 Mouse Mus musculus 10090 None None Parrot Psittacidae 9224 Pig Sus scrofa 9823 Rabbit Oryctolagus cuniculus 9986 Rainbow trout Oncorhynchus mykiss 8022 Rat Rattus 10114 Raven Corvus corax 56781 sei whale Balaenoptera borealis 9768 Sheep Ovis aries 9940 Squirrel Spermophilus richardsonii 37591 Tree shrew Tupaiidae 9393 Trouts, salmons & chars Salmoninae 504568 Turkey Meleagris gallopavo 9103 Vole Microtus ochrogaster 79684 Water buffalo Bubalus bubalis 391902 Actacel Diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b conjugate vaccine Actacel Sanofi Pasteur Ltd VO_0010705 Subunit vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins + Conjugate. Aluminum phosphate Refrigerate at 2° to 8°C. Intramuscular injection (i.m.) Adacel Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Adacel Sanofi Pasteur, Ltd (USA: License #1726) VO_0000005 Toxoid vaccine Licensed Intramuscular injection (i.m.) USA: License #1726 It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration. aluminum phosphate Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE 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). Intramuscular injection (i.m.) Pertussis Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response. (Adacel) 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). 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). Adacel-Polio Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine Adacel-Polio Sanofi Pasteur SA VO_0003085 Toxoid vaccine + Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada 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) Aluminum phosphate Store at 2° to 8°C (35° to 46°F), do not freeze. Intramuscular injection (i.m.) Boostrix Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Boostrix GlaxoSmithKline Biologicals VO_0000015 Toxoid vaccine Licensed Intramuscular injection (i.m.) USA (License #1617) 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). aluminum Phosphate Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. 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 . Intramuscular injection (i.m.) Prior to vaccination, antibody levels in subjects were 85.8% while after vaccination were 99.9% (Boostrix). 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). 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) Boostrix-Polio Combined diphtheria, tetanus, acellular pertussis (adsorbed) and inactivated poliomyelitis vaccine Boostrix-Polio GlaxoSmithKline VO_0003088 Toxoid vaccine + Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada 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) Aluminum hydroxide Store at 2° to 8°C (35° to 46°F), do not freeze. Intramuscular injection (i.m.) DAPTACEL Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed DAPTACEL Sanofi Pasteur, Ltd. VO_0000029 Toxoid vaccine Licensed USA (License #1726) 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. aluminum phosphate DAPTACEL vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE 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). 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). 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). Side effects of vaccination are: injection site reactions, irritability, fussiness, and lethargy. DECAVAC Tetanus and Diphtheria Toxoids Adsorbed For Adult Use DECAVAC Sanofi Pasteur, Inc VO_0000030 Toxoid vaccine Licensed Intramuscular injection (i.m.) USA (License #1725) 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). aluminum potassium sulfate Store at 2° to 8°C (35° to 46°F). Do not freeze. Do not use vaccine after expiration date. 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). Intramuscular injection (i.m.) A clinical study involving 58 individuals 6-58 years of age (FDA: Decavac). 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). 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) Diphtheria and Tetanus Toxoids Adsorbed Diphtheria and Tetanus Toxoids Adsorbed None Sanofi Pasteur Inc VO_0000033 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #1725), Canada 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). aluminum potassium sulfate Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. 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. Intramuscular injection (i.m.) 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). 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). 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). 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). DT Polio Adsorbed DT Polio Adsorbed Sanofi Pasteur Ltd VO_0010709 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins + killed virus. Other components: Formaldehyde. Aluminum phosphate Intramuscular injection (i.m.) Infanrix Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Infanrix GlaxoSmithKline Biologicals VO_0000064 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #1617) 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). Aluminum Hydroxide Store INFANRIX refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Intramuscular injection (i.m.) Efficacy of diphtheria toxoid used in INFANRIX was determined on the basis of immunogenicity studies (FDA: INFANRIX). 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). Side effects of vaccination include: injection site reactions, fever, irritability, drowsiness, loss of appetite, and vomiting (FDA: INFANRIX). Infanrix -IPV/Hib Infanrix -IPV/Hib GlaxoSmithKline VO_0010722 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins + killed virus + conjugate. Other components: Formaldehyde Polysorbate 80, Lactose. Aluminum hydroxide Store in a refrigerator (2°C – 8°C). Intramuscular injection (i.m.) Infanrix-hexa Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine Infanrix-hexa GlaxoSmithKline VO_0010719 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins + killed viruses + conjugate. Other components: Yeast protein Formaldehyde, Lactose, Polysorbate 20 and 80. Aluminum phosphate and aluminum hydroxide Should be stored at 2° to 8°C (35° to 46°F). Intramuscular injection (i.m.) Infanrix-IPV Infanrix-IPV GlaxoSmithKline VO_0010721 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins + killed virus. Other components: Formaldehyde, Polysorbate 80. Aluminum hydroxide Store in a refrigerator (2°C - 8°C). Intramuscular injection (i.m.) Infanrix/Hib Infanrix/Hib GlaxoSmithKline VO_0010720 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins + conjugate. Other components: Formaldehyde, Lactose. Aluminum hydroxide Store at 2°C – 8°C (in a refrigerator). Intramuscular injection (i.m.) KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine KINRIX GlaxoSmithKline Biologicals VO_0000067 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #1617) 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). Aluminum Hydroxide Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. 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). Intramuscular injection (i.m.) 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. After vaccination, antibody levels in clinical trials was determined to be between 85-100% for all subjects (FDA: KINRIX). 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). The most common side effects reported were: injection site reactions, fever, drowisness, and loss of appetite (FDA: KINRIX). licensed Diphtheria human vaccine Generic Unknown VO_0000735 Toxoid vaccine Licensed A generic representation of vaccines utilized to prevent diphtheria infection in humans, based on inactivated diphtheria toxin (toxoid) to elicit protective immunity. These vaccines are historically the most prevalent and effective form of diphtheria immunization. Pediacel Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine (Tetanus Protein – Conjugate) Pediacel Sanofi Pasteur Ltd VO_0010730 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins, killed virus + conjugate. Other components: Bovine serum Formaldehyde, Polysorbate 80. Aluminum phosphate Store at 2° to 8°C (35° to 46°F). Intramuscular injection (i.m.) Pediarix Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Pediarix GlaxoSmithKline Biologicals VO_0000082 Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #1617) 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). Aluminum hydroxide The vaccine should be refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. 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). Intramuscular injection (i.m.) In response to vaccination, all patients seem to have around 90-100% antibody response. 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). The most reported side effects included: injection site reactions, fever, drowsiness, loss of appetite and fussiness (FDA: Pediarix). Pentacel Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel Sanofi Pasteur Limited VO_0000084 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) USA (License #1726), Canada 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). Aluminum phosphate Store at 2° to 8°C (35° to 46°F). Do not freeze. 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). Intramuscular injection (i.m.) After vaccination, subjects achieved 90% or greater anti-PRP ≥0.15 μg/mL (FDA: Pentacel). 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). 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). Quadracel Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine Quadracel Sanofi Pasteur Ltd VO_0010736 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins + killed virus. Other components: Bovine albumin Formaldehyde, Glutaraldehyde, Polysorbate 80. Aluminum phosphate Store at 2 to 8C (35 to 46F). Do not freeze. Intramuscular injection (i.m.) Td Adsorbed Tetanus and Diphtheria Toxoids Adsorbed Td Adsorbed Sanofi Pasteur Ltd VO_0010739 Toxoid vaccine Licensed Intramuscular injection (i.m.) Canada 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. aluminum phosphate Store at 2º to 8ºC (35º to 46ºF). Intramuscular injection (i.m.) Td Polio Adsorbed Td Polio Adsorbed Sanofi Pasteur Ltd VO_0011482 Subunit vaccine + Inactivated or "killed" vaccine Licensed Intramuscular injection (i.m.) Canada 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. Aluminum phosphate Store at 2° to 8°C (35° to 46°F). Intramuscular injection (i.m.) TENIVAC Tetanus and Diphtheria Toxoids Adsorbed For Adult Use TENIVAC Sanofi Pasteur, Ltd VO_0000102 Toxoid vaccine Licensed Intramuscular injection (i.m.) USA (License #1726) Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.(Tenivac) Aluminum Phosphate TENIVAC vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. 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) Intramuscular injection (i.m.) 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). A clinical study evaluated 17 participants ages 6 to 56 years conducted in Canada (Tenivac). 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). Tetanus and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids, Adsorbed None MassBiologics VO_0000111 Toxoid vaccine Licensed Intramuscular injection (i.m.) USA 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) Aluminum phosphate Store at 2°C - 8°C (36°F - 46°F), do not freeze. Intramuscular injection (i.m.) Tripacel Pertussis Vaccine-Acellular, Combined with Diphtheria and Tetanus Toxoids (Adsorbed) Tripacel Sanofi Pasteur Ltd VO_0010742 Subunit vaccine Licensed Intramuscular injection (i.m.) Canada Products: Proteins. Other components: Formaldehyde, Glutaraldehyde. Aluminum phospate Store at 2° to 8°C. Intramuscular injection (i.m.) Tripedia Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tripedia Sanofi Pasteur, Inc. VO_0000112 Toxoid vaccine Licensed Intramuscular injection (i.m.) USA (License #1725) 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). aluminum potassium sulfate Store between 2 and 8 degrees Celsius. DO NOT FREEZE. 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). Intramuscular injection (i.m.) Complete immunization significantly reduces the risk of developing diptheria and protection lasts around 10 years. 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). Adacel website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172481.htm Boostrix website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172925.htm CDC: Diphtheria website http://www.cdc.gov/ncidod/dbmd/diseaseinfo/diptheria_t.htm FDA: DAPTACEL website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101572.htm FDA: Decavac website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094067.htm FDA: Diphtheria and Tetanus Toxoids Adsorbed website https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142732.pdf FDA: INFANRIX website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101568.htm FDA: KINRIX website https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM241453.pdf FDA: Menactra website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm176044.htm FDA: Pediarix website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm146759.htm FDA: Pentacel website https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109810.pdf FDA: Quadracel website https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM439903.pdf FDA: TENIVAC website https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM152826.pdf FDA: Tetanus and Diphtheria Toxoids Adsorbed website https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM164127.pdf FDA: Tripedia website http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101565.htm GSK: Boostrix-Polio website https://ca.gsk.com/media/589683/boostrix-polio.pdf GSK: Infanrix-hexa website http://ca.gsk.com/media/537989/infanrix-hexa.pdf GSK: Infanrix-IPV website http://ca.gsk.com/media/590851/infanrix-ipv.pdf GSK: Infanrix-IPV/Hib website http://ca.gsk.com/media/590970/infanrix-ipv-hib.pdf Holmes, 2000 journal Holmes RK 2000 181 Suppl 1 S156-167 The Journal of infectious diseases Khrustaleva et al., 2015 journal Khrustaleva TA, Khrustalev VV, Barkovsky EV, Kolodkina VL, Astapov AA 2015 63 2 235-244 Molecular immunology MicrobeWiki: C. diphtheriae website http://microbewiki.kenyon.edu/index.php/Corynebacterium_diphtheriae Product Monograph: Adacel-Polio website https://www.vaccineshoppecanada.com/document.cfm?file=adacel-polio_e.pdf Product Monograph: Pediacel website https://www.vaccineshoppecanada.com/document.cfm?file=Pediacel_E.pdf Product Monograph: Td Adsorbed website https://www.vaccineshoppecanada.com/document.cfm?file=td_adsorbed_e.pdf Product Monograph: Td Polio Adsorbed website https://www.vaccineshoppecanada.com/document.cfm?file=td_polio_adsorbed_e.pdf Textbook of Bacteriology website http://textbookofbacteriology.net/diphtheria