NCT01226953

Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 365 Days – 569 Days
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Conditions

• Haemophilus Influenzae Type b (Hib) Infection

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenzae type b (Hib) vaccine	Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2010-10-22
• Last updated: 2011-12-30

Locations

1 site across 1 country: China