NCT01025544
Completed
Phase 3
A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection
Novartis Vaccines0 sites846 target enrollmentSeptember 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Haemophilus Influenzae Type b (Hib) Infection
- Sponsor
- Novartis Vaccines
- Enrollment
- 846
- Primary Endpoint
- Anti-PRP antibody levels at day 31 post booster
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Toddlers 12-18 months of age who have previously participated in study M37P2.
Exclusion Criteria
- •Prior Hib booster administration.
- •History of serious reaction(s) following vaccination.
- •Vaccination within 14 days of study vaccination.
- •Known or suspected immune impairment.
- •For additional entry criteria please refer to the protocol.
Outcomes
Primary Outcomes
Anti-PRP antibody levels at day 31 post booster
Time Frame: 31 days after vaccination
Secondary Outcomes
- Solicited local and systemic reactions, AEs, and SAEs(30 days post vaccination)
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