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Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: April 10, 2006
Last updated: February 20, 2013
Last verified: February 2013

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

Condition Intervention Phase
Meningitis, Meningococcal
Biological: Meningococcal C
Biological: DTP/Hib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Antibody responses to MnCC and concomitant vaccines

Secondary Outcome Measures:
  • Safety and reactogenicity

Estimated Enrollment: 240
Study Start Date: June 1997
Study Completion Date: April 1998
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   7 Weeks to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy infants 7-10 weeks of age eligible to receive routine immunization
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Please refer to this study by its identifier: NCT00314041

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For United Kingdom,
  More Information Identifier: NCT00314041     History of Changes
Other Study ID Numbers: 6029A1 D110 P500
Study First Received: April 10, 2006
Last Updated: February 20, 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Conjugate vaccine
Immune memory
Meningococcal Vaccines

Additional relevant MeSH terms:
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017