Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age

Study Overview
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Brief Summary
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Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age

Official Title
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A Phase III, Single Center, Open Label, Uncontrolled Study to Evaluate the Immunogenicity, Safety and Tolerability, of the Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Premature and Non Premature Children at 3, 5, 11 Months of Age Concomitantly With a Hexavalent Infant Vaccine

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 children of 11 to 15 weeks of age Exclusion Criteria: Children who previously received any kind of Meningococcal C vaccine, DTaP-IPV-HBV-Hib vaccine or a Hepatitis B vaccine at birth Children who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, culture proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping Children who have had household contact with and/or intimate exposure to an individual with culture proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days

Ages Eligible for Study
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Minimum Age: 11 Weeks
Maximum Age: 15 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Meningococcal C Conjugate Vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine. |  |  | 
| safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine |  |  | 
| antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine. |  |  | 

 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