Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
Phase 3
Completed
- Conditions
- Haemophilus Influenzae Type b (Hib) Infection
- Registration Number
- NCT01025544
- Lead Sponsor
- Novartis Vaccines
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 846
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-PRP antibody levels at day 31 post booster 31 days after vaccination
- Secondary Outcome Measures
Name Time Method Solicited local and systemic reactions, AEs, and SAEs 30 days post vaccination