Clinical Trial: Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

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

Official Title: A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunc

Brief Summary:

Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.

Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: Antibody responses to MnCC and concomitant vaccines

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety and reactogenicity

Original Secondary Outcome: Same as current

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: April 10, 2006
Date Started: June 1997
Date Completion:
Last Updated: February 20, 2013
Last Verified: February 2013