Immunogenicity of the Booster Dose of Two MenC Vaccines

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.

Detailed Description
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Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.

Official Title
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Randomized, Open Label, Active Control, Parallel Assignment Clinical Trial to Evaluate the Immunogenicity of Polysaccharide Meningococcal C Vaccines Conjugated With Tetanus Toxoid or CRM197 Given as a Booster Dose at 14-18 Months of Life.

Conditions
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Meningococcal Infection

Intervention / Treatment
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* Biological: conjugated polysaccharide menC vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy toddlers of both sexes Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age) Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age. Informed consent signed by one or both parents who are adequately informed about the study. Exclusion Criteria: Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time Toddlers with severe chronic diseases Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study. Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease. Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B). Toddlers with personal history of convulsions. Toddlers with known bleeding disorder no controlled Toddlers with known congenital or acquired immunodeficiency Toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months. A toddler that under investigator opinion is probable to be lost during the follow-up A toddler that is currently included or is planned to be included in any other clinical trial. A toddler that under investigator opinion must not be included in the study due to other medical or social reasons.

Ages Eligible for Study
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Minimum Age: 14 Months
Maximum Age: 19 Months

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: MENC-CRM/MENC-CRM<br>Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine | Biological: conjugated polysaccharide menC vaccine<br>* Booster vaccine dose at 14 to 18 months.<br>|
| Experimental: MENC-CRM/MENC-TT<br>Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT | Biological: conjugated polysaccharide menC vaccine<br>* Booster vaccine dose at 14 to 18 months.<br>|
| Experimental: MENC-TT/MENC-CRM<br>Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine | Biological: conjugated polysaccharide menC vaccine<br>* Booster vaccine dose at 14 to 18 months.<br>|
| Experimental: MENC-TT/MENC-TT<br>Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine | Biological: conjugated polysaccharide menC vaccine<br>* Booster vaccine dose at 14 to 18 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Bactericidal Activity Against MenC |  | One month after booster dose | 
| Serum Antibody Titers Against Haemophilus Influenzae Type b. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal vaccine, Immunization, secondary, vaccines conjugated, Meningococcal disease