Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314041

Enrollment

240

Registered

2006-04-12

Start date

1997-06-30

Completion date

1998-04-30

Last updated

2013-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis, Meningococcal

Keywords

Infant, Conjugate vaccine, Meningococcal, Antibody, Immune memory, Health, Meningococcal Vaccines

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

Interventions

BIOLOGICALMeningococcal C

BIOLOGICALDTP/Hib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

7 Weeks to 10 Weeks

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Antibody responses to MnCC and concomitant vaccines	—

Secondary

Measure	Time frame
Safety and reactogenicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026