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Baytet (Tetanus Immune Globulin) - 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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Published Studies Related to Baytet (Tetanus Immune Globulin)

Phase II and III Clinical Studies of Diphtheria-Tetanus-Acellular Pertussis Vaccine Containing Inactivated Polio Vaccine Derived from Sabin Strains (DTaP-sIPV). [2013]
vaccine (DTaP)... CONCLUSIONS: DTaP-sIPV was shown to be a safe and immunogenic vaccine.

An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. [2011.06.06]
Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months.ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.

Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06]
BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.

Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. [2011.04]
Hib-primed but MenC-naive toddlers (N = 433) were randomized to receive 1 dose of Hib-MenC-TT or separate Hib-TT and MenC-CRM197 vaccines. One month later, noninferiority was demonstrated for serum bactericidal anti-MenC antibodies (rSBA) and Hib antipolyribosylribitol phosphate (PRP) antibodies; >99% in both groups had rSBA titer >/= 8 or anti-PRP concentration >/= 0.15 mug/mL.

Immunogenicity and safety of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus type b conjugate vaccine when administered concurrently with a pneumococcal conjugate vaccine: a randomized, open-label, phase 3 study. [2011.03.03]
A phase 3 randomized, multicenter study evaluated the safety and immunogenicity of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine (DTaP(5)-IPV/Hib) administered at the same visit with 7-valent pneumococcal conjugate vaccine (PCV7, concurrent group) or at separate visits (separated by >/= 15 days; staggered group).

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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.

A Phase 3b Study of BG00012's Effect on Vaccination Response in Subjects With Relapsed Forms of Multiple Sclerosis [Not yet recruiting]
The primary objective of the study is to evaluate the effects of BG00012 (Dimethyl Fumarate) administered over approximately 6 months on immune responses to vaccination with tetanus diphtheria toxoids vaccine (Td) [T cell-dependent anamnestic humoral response] and keyhole limpet hemocyanian (KLH) [T cell-dependent neoantigen response] in subjects with relapsing forms of multiple sclerosis (MS). Secondary objectives are: To evaluate the effects of BG00012 administered over approximately 6 months on the immune response to vaccination with Pneumococcal Vaccine (Pneumovax 23) [a mostly T cell-independent humoral response]; To evaluate the pharmacodynamic effects of BG00012 on lymphocyte subtypes over 1 year of treatment; To evaluate the pharmacodynamic effect of BG00012 immunoglobulin levels over time and To evaluate the safety and tolerability of BG00012

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Page last updated: 2014-11-30

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