Clinical Trial: Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197)

Brief Summary: 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.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome: Anti-PRP antibody levels at day 31 post last vaccination [ Time Frame: 30 days after last vaccination ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Solicited local and systemic reactions, AEs, and SAEs [ Time Frame: 30 days post last vaccination ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: May 14, 2010
Date Started: August 2009
Date Completion:
Last Updated: November 30, 2016
Last Verified: December 2011