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NCT00314041 Clinical Trial

Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

Meningitis, Meningococcal Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00314041
Other study ID # 6029A1 D110 P500
Secondary ID
Status Completed
Phase Phase 2
First received April 10, 2006
Last updated February 20, 2013
Start date June 1997
Est. completion date April 1998

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date April 1998
Est. primary completion date April 1998
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Weeks to 10 Weeks
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Meningococcal C

• DTP/Hib

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Antibody responses to MnCC and concomitant vaccines
Secondary Safety and reactogenicity
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