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

Phase 3

Completed

• Conditions: Prevention of Meningococcal Infection
• Interventions: Biological: Meningococcal C conjugate vaccine

• Registration Number: NCT00311415
• Lead Sponsor: Novartis Vaccines

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-06
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-06
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: 2+4 Months (2-doses)	Meningococcal C conjugate vaccine	-
Group 2: 2 Months (1-dose)	Meningococcal C conjugate vaccine	-
Group 3: 6 Months (1-dose)	Meningococcal C conjugate vaccine	-
Group 4: 12-16 Months (1 dose in the second year of life)	Meningococcal C conjugate vaccine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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