Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
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
2 other identifiers
interventional
257
2 countries
2
Brief Summary
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2005
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 3, 2006
CompletedFirst Posted
Study publicly available on registry
April 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFebruary 8, 2012
February 1, 2012
2.5 years
April 3, 2006
February 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Overall study period
Secondary Outcomes (1)
Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA.
Overall study period
Study Arms (4)
Group 1: 2+4 Months (2-doses)
EXPERIMENTALGroup 2: 2 Months (1-dose)
EXPERIMENTALGroup 3: 6 Months (1-dose)
EXPERIMENTALGroup 4: 12-16 Months (1 dose in the second year of life)
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- healthy infants
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Mainz, Kehl, Neumünster, Ettenheim, Germany
Unknown Facility
Kraków, Lubartów, Lublin, Bydgosczcz, Poland
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis Vaccines - Information Services
Novartis Vaccines & Diagnostics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2006
First Posted
April 6, 2006
Study Start
October 1, 2005
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
February 8, 2012
Record last verified: 2012-02