A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

NCT01125527 Phase 3 COMPLETED

This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	COMPLETED
Enrolment	700
Start date	2009-08
Completion	2010-04

Conditions

• Haemophilus Influenzae Type b (Hib) Infection

Interventions

• Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
• Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

Primary outcomes

• Anti-PRP antibody levels at day 31 post last vaccination — 30 days after last vaccination

Countries

China