Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

Phase 2

Completed

• Conditions: Meningitis, Meningococcal

• Registration Number: NCT00314041
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Description

Not available

Study Timeline

• Study Start: 1997-06
• Primary Completion: 1998-04
• Study Completion: 1998-04
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Healthy infants 7-10 weeks of age eligible to receive routine immunization

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antibody responses to MnCC and concomitant vaccines

Secondary Outcome Measures

Name	Time	Method
Safety and reactogenicity