Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

Wyeth

Status and phase: Completed; Phase 2

Conditions: Meningitis, Meningococcal

Treatments: Biological: Meningococcal C; Biological: DTP/Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314041

6029A1 D110 P500

Details and patient eligibility

About

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

Sex: All

Ages: 7 to 10 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind