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Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00310635
First received: April 3, 2006
Last updated: October 25, 2006
Last verified: October 2006
History of Changes
  Purpose

Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age


Condition Intervention Phase
Meningococcal Infection
 Biological: Meningococcal C conjugate vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.

Secondary Outcome Measures:
  • Determination of antibody titers in naïve control subjects.
  • Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age.
  • Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.

Estimated Enrollment: 241
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   32 Months to 40 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children

Exclusion Criteria:

  • known hypersensitivity to any vaccine component
  • significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
  • ascertained or suspected disease caused by N. meningitidis
  • household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310635

Locations
Germany
Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,
Oppenheim,, Kempten, Germany
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Principal Investigator: Vaccines - Information Services Novartis Vaccines & Diagnostics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00310635     History of Changes
Other Study ID Numbers: M14P1E1, Impact N° 1453
Study First Received: April 3, 2006
Last Updated: October 25, 2006
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Prevention of meningococcal infection

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

ClinicalTrials.gov processed this record on May 21, 2013