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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00311415
First received: April 3, 2006
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Prevention of Meningococcal Infection
Biological: Meningococcal C conjugate vaccine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: October 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   7 Weeks to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311415

Locations
Germany
Mainz, Kehl, Neumünster, Ettenheim, Germany
Poland
Kraków, Lubartów, Lublin, Bydgosczcz, Poland
Sponsors and Collaborators
Novartis Vaccines
Investigators
Principal Investigator: Novartis Vaccines - Information Services Novartis Vaccines & Diagnostics
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00311415     History of Changes
Other Study ID Numbers: M14P6, Impact N° 919
Study First Received: April 3, 2006
Last Updated: February 6, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Poland: Office for Registration of Medicinal Products Medical Devices and Biocides

Keywords provided by Novartis:
Prevention of Meningococcal Meningitis
meningococcal vaccines
conjugate
immunology
infant
antibody persistence

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014