NCT01044316
Completed
Phase 3
A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Using a Local Dosing Regimen in Infants
Novartis Vaccines0 sites670 target enrollmentApril 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Haemophilus Influenzae Type b (Hib) Infection
- Sponsor
- Novartis Vaccines
- Enrollment
- 670
- Primary Endpoint
- Anti-PRP antibody levels at day 31 post last vaccination
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Anti-PRP antibody levels at day 31 post last vaccination
Time Frame: 30 days after last vaccination
Secondary Outcomes
- Solicited local and systemic reactions, AEs, and SAEs(30 days post last vaccination)
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