Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age; and in Comparison to One Dose Given at 12-16 Months of Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311415

Enrollment

257

Registered

2006-04-06

Start date

2005-10-31

Completion date

2008-04-30

Last updated

2012-02-08

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

Conditions

Prevention of Meningococcal Infection

Keywords

Prevention of Meningococcal Meningitis, meningococcal vaccines, conjugate, immunology, infant, antibody persistence

Brief summary

Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

Detailed description

The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.

Interventions

BIOLOGICALMeningococcal C conjugate vaccine

Meningococcal conjugate vaccine, active comparator. Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Weeks to 16 Weeks

Healthy volunteers

Yes

Inclusion criteria

* healthy infants

Exclusion criteria

* known hypersensitivity to any vaccine component * significant acute or chronic infections * previously ascertained or suspected disease caused by N. meningitidis * previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Design outcomes

Primary

Measure	Time frame
Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA.	Overall study period

Secondary

Measure	Time frame
Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.	Overall study period

Countries

Germany, Poland

Outcome results

None listed

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