Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00314041
First received: April 10, 2006
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
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)
  Eligibility

Ages Eligible for Study:   7 Weeks to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants 7-10 weeks of age eligible to receive routine immunization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00314041     History of Changes
Other Study ID Numbers: 6029A1 D110 P500
Study First Received: April 10, 2006
Last Updated: February 20, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014