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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014