Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.

Detailed Description
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The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.

Official Title
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Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec

Conditions
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Neisseria Meningitidis, Haemophilus Influenzae Type b

Intervention / Treatment
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* Biological: Haemophilus influenzae type b- and meningococcal (vaccine)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male or female between, and including, 13 and 14 months of age Having participated in the primary vaccination study 217744/097. Exclusion criteria: Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097 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

Ages Eligible for Study
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Minimum Age: 13 Months
Maximum Age: 14 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: Haemophilus influenzae type b- and meningococcal (vaccine)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128 |  |  | 
| Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3 |  |  | 
| Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc. |  |  | 
| SAEs for whole study |  |  |