NCT00808392

Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 916 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 2 Months – 4 Months
• Healthy volunteers: Accepted

Summary

This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.

Conditions

• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenzae type b vaccine	3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
BIOLOGICAL	Commercial Haemophilus influenzae type b vaccine	3 doses one month apart of Haemophilus influenzae type b vaccine.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-12-15
• Last updated: 2011-12-29

Locations

2 sites across 1 country: China