Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With...
DiphtheriaTetanus3 moreObjectives: To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants...
DiphtheriaTetanus3 moreThe study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months) Secondary Objectives: To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series. To assess the overall safety in each group one month after each dose of the primary series and through the entire study.
Pertussis Maternal Immunization Study
Pregnant WomenThe purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine...
DiphtheriaTetanus3 moreDTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. Primary Objectives: To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth. To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth. Secondary Objective: To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
Acellular PertussisTetanus1 moreThe purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T...
DiphtheriaTetanus4 moreThis is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™. To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects. Safety - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.
Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis...
DiphtheriaTetanus2 morePrimary objective: To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects Secondary objectives: If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years To describe the immune responses to REPEVAX in these subjects To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects
Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
TetanusDiphtheria1 moreObjectives: To provide safety data on revaccination with ADACEL® vaccine. To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination...
DiphtheriaAcellular Pertussis4 moreIn this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at...
DiphtheriaTetanus3 moreTo demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject. To evaluate the overall safety in terms of: Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial. Immunogenicity: To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.