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Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

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ClinicalTrials.gov Identifier: NCT00314041
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : February 21, 2013
Sponsor:
Information provided by:
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


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

Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : June 1997
Actual Primary Completion Date : April 1998
Actual Study Completion Date : April 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Antibody responses to MnCC and concomitant vaccines

Secondary Outcome Measures :
  1. Safety and reactogenicity


Information from the National Library of Medicine

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

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314041


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For United Kingdom, ukmedinfo@wyeth.com

ClinicalTrials.gov Identifier: NCT00314041     History of Changes
Other Study ID Numbers: 6029A1 D110 P500
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Meningitis
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs