NCT01044316

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 670 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

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.

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 - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2010-01-07
• Last updated: 2011-12-30

Locations

1 site across 1 country: China