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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00317109 |
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Infection Meningococcal Infection |
Biological: Mencevax™ ACW Biological: Tritanrix™- HepB Biological: Hiberix™ |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007 |
Enrollment: | 168 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AC unprimed Group: Active Comparator |
Biological: Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
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AC primed Group: Experimental |
Biological: Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
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This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.
Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.
Ages Eligible for Study: | 15 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
South Africa | |
GSK Investigational Site | |
Rooihuiskraal, South Africa, 0145 | |
GSK Investigational Site | |
Brits, South Africa, 0250 | |
GSK Investigational Site | |
Ga-Rankuwa, South Africa, 0208 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104756 |
Study First Received: | February 3, 2006 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00317109 |
Health Authority: | South Africa: Department of Health |
Prophylaxis diphtheria tetanus pertussis hepatitis B |
Haemophilus influenzae type b meningococcal serogroups A and C diseases meningococcal vaccine |
Haemophilus Infections Bacterial Infections Liver Diseases Haemophilus influenzae Hepatitis, Viral, Human Whooping Cough Cough Diphtheria Tetanus Whooping cough Meningococcal infection Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Meningococcal Infections Hepatitis B Influenza, Human DNA Virus Infections Clostridium Infections Neisseriaceae Infections |
Bordetella Infections Pasteurellaceae Infections Communicable Diseases Corynebacterium Infections |
Infection Hepadnaviridae Infections Actinomycetales Infections |