Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy Toddlers

Study Overview
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Brief Summary
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The purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.

Detailed Description
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The study is an extension of the primary vaccination study 711202/001 (MenC-TT-001). It comprises 5 groups: 4 parallel groups of toddlers vaccinated in study 711202/001 (group vaccinated with Meningitec™ is control group 1) and 1 group of naive subjects (no previous vaccination against MenC disease, control group 2). All subjects receive 1/5th dose Mencevax™ ACWY and a concomitant dose of Infanrix hexa®. 2 blood samples: prior to and 1 month after vaccination.

Official Title
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Evaluate the Persistence and Immune Memory Induced by a Primary Vaccination Course With GSK Biologicals' MenC-TT (1 Formulation) & GSK Biologicals' Hib-MenC-TT (2 Formulations) or Meningitec™ in Healthy Toddlers Aged 12-15 Months Primed in Study 711202/001

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Biological: MenC-TT
* Biological: Hib-MenC-TT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunization (STIKO) recommendation at least 6 months before enrolment Exclusion Criteria: Previous/intercurrent booster vaccination against OR history of OR exposure to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease. Planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of Infanrix hexa®. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. A family history of congenital or hereditary immunodeficiency. History of any neurologic disorders or seizures, of allergic disease/reactions likely to be exacerbated by any component of the vaccines

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MenC-TT|nan|
|Biological: Hib-MenC-TT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prior to dose 1, 1 m post doses 2, 3: anti-PRP |  |  | 
| Prior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN |  |  | 
| Solicited (days [d] 0-7), unsolicited (up to 30 d) adverse events (AEs) after each dose |  |  | 
| Serious adverse events (SAEs) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilus Influenzae type b/Meningococcal (vaccine), Prophylaxis meningococcal serogroup C disease, Hib diseases