Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

Wyeth is now a wholly owned subsidiary of Pfizer240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

240

Conditions

Meningitis, Meningococcal

Interventions

Meningococcal CBIOLOGICAL

DTP/HibBIOLOGICAL

Eligibility

Sex: ALLMin age: 7 WeeksMax age: 10 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Antibody responses to MnCC and concomitant vaccines

Secondary Outcomes

Safety and reactogenicity

Data from ClinicalTrials.gov

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