Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

NCT ID: NCT00314041

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-06-30

Study Completion Date

1998-04-30

Brief Summary

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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

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Conditions

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Meningitis, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Meningococcal C

Intervention Type BIOLOGICAL

DTP/Hib

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy infants 7-10 weeks of age eligible to receive routine immunization
Minimum Eligible Age

7 Weeks

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For United Kingdom, [email protected]

Other Identifiers

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6029A1 D110 P500

Identifier Type: -

Identifier Source: org_study_id

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