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Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

Primary Purpose

Meningitis, Meningococcal

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Meningococcal C

DTP/Hib

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring Infant, Conjugate vaccine, Meningococcal, Antibody, Immune memory, Health, Meningococcal Vaccines

Eligibility Criteria

7 Weeks - 10 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy infants 7-10 weeks of age eligible to receive routine immunization

Sites / Locations

Outcomes

Primary Outcome Measures

Antibody responses to MnCC and concomitant vaccines

Secondary Outcome Measures

Safety and reactogenicity

Full Information

NCT ID

NCT00314041

First Posted

April 10, 2006

Last Updated

February 20, 2013

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00314041

Brief Title

Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

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 Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

June 1997 (undefined)

Primary Completion Date

April 1998 (Actual)

Study Completion Date

April 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Meningococcal

Keywords

Infant, Conjugate vaccine, Meningococcal, Antibody, Immune memory, Health, Meningococcal Vaccines

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

240 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Meningococcal C

Intervention Type

Biological

Intervention Name(s)

DTP/Hib

Primary Outcome Measure Information:

Title

Antibody responses to MnCC and concomitant vaccines

Secondary Outcome Measure Information:

Title

Safety and reactogenicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Weeks

Maximum Age & Unit of Time

10 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy infants 7-10 weeks of age eligible to receive routine immunization

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Trial Manager

Organizational Affiliation

For United Kingdom, ukmedinfo@wyeth.com

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

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