Back to resultsSafety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Primary Purpose
Meningococcal Infection
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Meningococcal C conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Infection focused on measuring Prevention of meningococcal infection
Eligibility 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
Sites / Locations
- Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,
Outcomes
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.
Full Information
NCT ID
NCT00310635
First Posted
April 3, 2006
Last Updated
October 25, 2006
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00310635
Brief Title
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infection
Keywords
Prevention of meningococcal infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
241 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Meningococcal C conjugate vaccine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Determination of antibody titers in naïve control subjects.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Months
Maximum Age & Unit of Time
40 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaccines - Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,
City
Oppenheim,
State/Province
Kempten
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
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