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10 single dose vials
Age 7 years or older
Tetanus and Diphtheria Toxoids Adsobed (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.
Corynebacterium diphtheriae and Clostridium tetani organisms are grown on modified Mueller's media which contains bovine extracts.
The bovine material used in these extracts is sourced from countries which the United States Department of Agriculture has determined neither have nor present an undue risk for bovine spongiform encephalopathy.
Tetanus and diphtheria toxins produced during growth of the cultures are detoxified with formaldehyde.
The detoxified materials are then separately purified by ammonium sulfate fractionation.
The diphtheria toxoid is further purified by column chromatography.
The tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.
The tetanus and diphtheria toxoids induce at least 2 units and 1 unit of antitoxin per ml of serum, respectively, in the guinea pig potency test.
Tetanus (also known as lockjaw) is a serious, often fatal disease caused by an extremely potent neurotoxin produced by C. tetani.
Protection against disease is due to the development of neutralizing antibodies to tetanus toxin.
A serum tetanus antitoxin level of 0.01 IU/ml measured via a neutralization assay is considered the minimum protective level.
The efficacy against tetanus of MassBiologics' Td is supported by the following
Response to primary series. Of 20 adults with less than 0.0025 units/ml of tetanus antitoxin in pre-immunization serum, 14 (70%) had antitoxin concentrations of 0.01 or greater after 2 doses of Td (2 Lf tetanus toxoid dose). After 3 doses of Td, 16 of 16 adults achieved 0.01 antitoxin units/ml.
Response to booster doses. Booster doses of Td at doses of 1 Lf and 5 Lf of tetanus toxoid induced tetanus antitoxin levels greater than 0.01 units/ml when administered to all 36 adults who had received prior tetanus immunizations.
It is an acute toxin-mediated disease caused by toxigenic strains of C. diphtheriae.
Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin.
A serum diphtheria antitoxin level of 0.01 IU/ml is the lowest level giving some degree of protection.
The efficacy against diphtheria of MassBiologics' Td is supported by the following
Response to primary series. Of 10 adults with less than 0.001 units/ml of diphtheria antitoxin in pre-immunization serum, 50% had antitoxin concentrations of 0.01 or greater after 2 doses of Td (2 Lf diphtheria toxoid dose). After 3 doses of Td, 6 of 6 adults achieved 0.01 antitoxin units/ml.
Response to booster doses. In clinical trials, booster doses of Td formulated to contain 1 Lf and 5 Lf of diphtheria toxoid, both induced antitoxin levels greater than 0.01 units/ml when administered to adults with prior diphtheria immunity. In 140 adolescent males given a single booster dose of the 1 Lf formulation, all achieved an antitoxin titer of 0.01 units/ml or higher.