BAYTET SUMMARY
Tetanus Immune Globulin (Human) -- BayTet® treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular administration; it contains no preservative. BayTet is prepared by cold ethanol fractionation from the plasma of donors immunized with tetanus toxoid. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayTet is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. BayTet is then incubated in the final container for 21-28 days at 20-27°C. The product is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per container.
BayTet is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus. 7, 8, 15
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NEWS HIGHLIGHTS
Published Studies Related to Baytet (Tetanus Immune Globulin)
Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 3, 4, and 12-14 months of age. [2009.04.28]
Combination vaccines improve parental and provider satisfaction and schedule compliance by decreasing the number of injections. In a Phase 2, randomized, double-blind, multicenter study, we compared four formulations of a liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B virus (DTaP-IPV-Hib-HBV) vaccine in 708 infants immunized at 2, 3, 4, and 12-14 months of age...
Booster vaccination of toddlers with reduced antigen content diphtheria -- tetanus -- acellular pertussis vaccine. [2009.04.21]
Immunogenicity and reactogenicity of DTPa and reduced antigen dTpa booster vaccines were compared to a hepatitis A control vaccine in DTPa-primed toddlers aged 18 - 20 months. Post-booster, all DTPa and dTpa recipients were seroprotected against diphtheria and tetanus, and > or = 93.3% had a booster response to pertussis...
Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. [2009.03]
BACKGROUND: The pentavalent rotavirus vaccine (PRV), RotaTeq, can be concomitantly administered with most routine childhood vaccines. This study evaluated the immunogenicity and reactogenicity of PRV when used concomitantly with a hexavalent vaccine containing diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b... CONCLUSIONS: In this study, concomitant administration of PRV with hexavalent vaccine was well tolerated and the immune responses to the antigens of the hexavalent vaccine were noninferior when compared with those of the control group. In addition, PRV was immunogenic when administered concomitantly with hexavalent vaccine.
Booster vaccination of adults with reduced-antigen-content diphtheria, Tetanus and pertussis vaccine: immunogenicity 5 years post-vaccination. [2009.02.11]
At 60 months post-vaccination, adults (mean age 45.6 years) randomised to receive combined reduced-antigen-content diphtheria-tetanus and acellular pertussis vaccine (dTpa) versus tetanus-diphtheria (Td)+monovalent acellular pertussis (pa) were seroprotected against diphtheria (> or =0.016IU/mL Vero cell assay) and tetanus (> or =0.1IU/mL ELISA assay) in 94.4% and 96.2%, respectively (dTpa), compared with 93.7% and 90.6% (Td+pa).
Humoral immune response after post-chemotherapy booster diphtheria-tetanus-pertussis vaccine in pediatric oncology patients. [2009.02]
BACKGROUND: The role of post-chemotherapy booster vaccination in pediatric oncology children remains to be established. In this randomized controlled study, we studied the effect of immune responses to diphtheria-tetanus-pertussis (DTP) booster vaccination in children 6 months after completing chemotherapy... CONCLUSIONS: Post-chemotherapy booster vaccinations produced a strong and sustained effect in humoral immunity against vaccine-preventable infectious diseases. (c) 2008 Wiley-Liss, Inc.
Clinical Trials Related to Baytet (Tetanus Immune Globulin)
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels [Terminated]
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when
Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given
concurrently with strict control on the anatomical location and timing of administration of
TIG and TT. Pharmacokinetic profile of antibody titer including the duration of adequate
titer protection provided by TIG and TT given in combination will be assessed using a
standardized administration regimen and standardized antibody assay procedure. This study may
provide evidence for the recommendations of the World Health Organisation (WHO) whereby dual
coverage with both a vaccine and tetanus hyperimmune would ideally provide the best coverage
for anyone with the potential of developing tetanus.
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Page last updated: 2009-10-20
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