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

February 6, 2012 updated by: Novartis Vaccines

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Kehl, Neumünster, Ettenheim, Germany
  • Poland
      • Kraków, Lubartów, Lublin, Bydgosczcz, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: 2+4 Months (2-doses)
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
Experimental: Group 2: 2 Months (1-dose)
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
Experimental: Group 3: 6 Months (1-dose)
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
Active Comparator: Group 4: 12-16 Months (1 dose in the second year of life)
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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Overall study period
Overall study period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Investigators

  • Principal Investigator: Novartis Vaccines - Information Services, Novartis Vaccines & Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

April 3, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14P6
  • Impact N° 919

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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