Back to resultsImmunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
Primary Purpose
Prevention of Meningococcal Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Meningococcal C conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Meningococcal Infection focused on measuring Prevention of Meningococcal Meningitis, meningococcal vaccines, conjugate, immunology, infant, antibody persistence
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Group 1: 2+4 Months (2-doses)
Group 2: 2 Months (1-dose)
Group 3: 6 Months (1-dose)
Group 4: 12-16 Months (1 dose in the second year of life)
Arm Description
Outcomes
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.
Secondary Outcome Measures
Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00311415
Brief Title
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Meningococcal Infection
Keywords
Prevention of Meningococcal Meningitis, meningococcal vaccines, conjugate, immunology, infant, antibody persistence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: 2+4 Months (2-doses)
Arm Type
Experimental
Arm Title
Group 2: 2 Months (1-dose)
Arm Type
Experimental
Arm Title
Group 3: 6 Months (1-dose)
Arm Type
Experimental
Arm Title
Group 4: 12-16 Months (1 dose in the second year of life)
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Meningococcal C conjugate vaccine
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Principal Investigator
Facility Information:
City
Mainz, Kehl, Neumünster, Ettenheim
Country
Germany
City
Kraków, Lubartów, Lublin, Bydgosczcz
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
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