NCT00311415

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 7 Weeks – 16 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Prevention of Meningococcal Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-04-06
• Last updated: 2012-02-08

Locations

2 sites across 2 countries: Germany, Poland