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
  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:


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
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: 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:
Infection
Meningococcal Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on October 23, 2014