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

Prevention of Meningococcal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311415
• Other study ID #: M14P6
• Secondary ID: Impact N° 919
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2006
• Last updated: February 6, 2012
• Start date: October 2005
• Est. completion date: April 2008

Study information

• Verified date: February 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutPoland: Office for Registration of Medicinal Products Medical Devices and Biocides
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Weeks to 16 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Infections
• Prevention of Meningococcal Infection

Intervention

Biological:
• Meningococcal 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.		Overall study period	No