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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00136604 |
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix™-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Infections Meningococcal Infections |
Biological: Diphtheria-tetanus-pertussis-hep B/Hib-meningococcal A&C |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax™ ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix™-HepB/Hib-MenAC |
Estimated Enrollment: | 1000 |
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax™ ACWY phase at 24-30 months a dose of Mencevax™ ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax™ ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.
Ages Eligible for Study: | 427 Days to 730 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Study ID Numbers: | 104727 (Booster - 15-24 mths), 104730 (Booster - 24-30 mths) |
Study First Received: | August 26, 2005 |
Last Updated: | June 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00136604 History of Changes |
Health Authority: | Thailand: Ethical Committee |
Prophylaxis diphtheria Hib & meningococcal serogroup A & C disease |
Haemophilus Infections Bacterial Infections Liver Diseases Hepatitis, Viral, Human Whooping Cough Cough Meningococcal Infection Diphtheria Tetanus Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Meningococcal Infections Hepatitis B DNA Virus Infections Neisseriaceae Infections |
Haemophilus Infections Bacterial Infections Pasteurellaceae Infections Communicable Diseases Liver Diseases Hepatitis, Viral, Human Whooping Cough Diphtheria Infection Hepadnaviridae Infections Actinomycetales Infections Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Bordetella Infections Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Corynebacterium Infections Meningococcal Infections Hepatitis B DNA Virus Infections Neisseriaceae Infections |