Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China
Phase 3
Completed
- Conditions
- Haemophilus Influenzae Type b (Hib) Infection
- Registration Number
- NCT01044316
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 670
Inclusion Criteria
- Infants 6-12 months of age.
Exclusion Criteria
- Prior Hib vaccine administration.
- History of serious reaction(s) following vaccination.
- Any 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 last vaccination 30 days after last vaccination
- Secondary Outcome Measures
Name Time Method Solicited local and systemic reactions, AEs, and SAEs 30 days post last vaccination