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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014