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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00696423 |
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Haemophilus Influenzae Type b Disease |
Biological: Hiberix Biological: Infanrix |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children |
Enrollment: | 466 |
Study Start Date: | June 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Group A: subjects in this group will receive the Infanrix/Hib vaccine
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Biological: Hiberix
Intramuscular injection, one dose
Biological: Infanrix
Intramuscular injection, one dose
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Group B: Active Comparator
Group B: subjects in this group will receive two separate injections of Infanrix and Hiberix vaccines
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Biological: Hiberix
Intramuscular injection, one dose
Biological: Infanrix
Intramuscular injection, one dose
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Ages Eligible for Study: | 18 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Occurrence of any of the following adverse events (AEs) after previous administration of a DTP vaccine:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111535 |
Study First Received: | June 5, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00696423 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Chinese children Infanrix/Hib |
Bacterial Infections Haemophilus Influenzae Whooping Cough Cough Diphtheria Orthomyxoviridae Infections Tetanus |
Gram-Negative Bacterial Infections Virus Diseases Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Influenza, Human |
Bacterial Infections RNA Virus Infections Whooping Cough Diphtheria Orthomyxoviridae Infections Infection Actinomycetales Infections Gram-Negative Bacterial Infections |
Virus Diseases Bordetella Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Corynebacterium Infections Influenza, Human |