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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:
ClinicalTrials.gov Identifier:
NCT00310635
First Posted: April 4, 2006
Last Update Posted: October 26, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Months to 40 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00310635     History of Changes
Other Study ID Numbers: M14P1E1
Impact N° 1453
First Submitted: April 3, 2006
First Posted: April 4, 2006
Last Update Posted: October 26, 2006
Last Verified: October 2006

Keywords provided by Novartis:
Prevention of meningococcal infection

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs