Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

Study Overview
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Brief Summary
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Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

Detailed Description
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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.

Official Title
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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

Conditions
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Prevention of Meningococcal Infection

Intervention / Treatment
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* Biological: Meningococcal C conjugate vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Weeks
Maximum Age: 16 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: 2+4 Months (2-doses)<br> | Biological: Meningococcal C conjugate vaccine<br>* 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<br>|
| Experimental: Group 2: 2 Months (1-dose)<br> | Biological: Meningococcal C conjugate vaccine<br>* 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<br>|
| Experimental: Group 3: 6 Months (1-dose)<br> | Biological: Meningococcal C conjugate vaccine<br>* 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<br>|
| Active Comparator: Group 4: 12-16 Months (1 dose in the second year of life)<br> | Biological: Meningococcal C conjugate vaccine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA. |  | Overall study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Meningococcal Meningitis, meningococcal vaccines, conjugate, immunology, infant, antibody persistence