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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00325143 |
To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. 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, Polio, Haemophilus Influenzae Type B |
Biological: DTPa-HBV-IPV/Hib Biological: DTPa-IPV/Hib vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age |
Enrollment: | 702 |
Study Start Date: | December 2003 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Biological: DTPa-HBV-IPV/Hib
1 intramuscular injection (3rd study vaccine dose)
Biological: DTPa-IPV/Hib vaccine
3 intramuscular injections (1st, 2nd and 4th vaccine dose)
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Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.
Ages Eligible for Study: | 11 Weeks to 17 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria
Exclusion criteria
Singapore | |
GSK Investigational Site | |
Singapore, Singapore, 119074 | |
GSK Investigational Site | |
Singapore, Singapore, 228510 | |
GSK Investigational Site | |
Singapore, Singapore, 229899 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 217744/100 |
Study First Received: | February 8, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00325143 |
Health Authority: | Singapore: Singapore Regulatory Authority |
Bacterial Infections Liver Diseases Haemophilus influenzae Hepatitis, Viral, Human Whooping Cough Cough Diphtheria Tetanus Whooping cough Gram-Negative Bacterial Infections Pentetic Acid |
Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Hepatitis B Influenza, Human DNA Virus Infections Iron |
Bordetella Infections Molecular Mechanisms of Pharmacological Action Corynebacterium Infections Physiological Effects of Drugs Iron Chelating Agents Chelating Agents |
Infection Protective Agents Hepadnaviridae Infections Pharmacologic Actions Actinomycetales Infections Antidotes |