Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants

Study Overview
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Brief Summary
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The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.

Detailed Description
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Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.

Official Title
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Evaluate Immunogenicity, Reactogenicity, Safety of GSK Biologicals' MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals' Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life

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 male or female infants, 8 to 16 weeks of age at the time of the first vaccination. Exclusion Criteria: Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease. Planned administration/administration of a vaccine not foreseen in the study since birth. 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, allergic disease or reactions likely to be exacerbated by any component of the vaccine

Ages Eligible for Study
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Minimum Age: 8 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

| 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 |
| --- | --- | --- |
| Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers |  | Prior to vaccination, one month after the 2nd and 3rd vaccine doses | 
| Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations |  | Prior to vaccination, one month after the 2nd and 3rd vaccine doses | 
| Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations |  | Prior to vaccination, one month after the 2nd and 3rd vaccine doses | 
| Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA |  | Prior to and one month after the 3rd vaccine dose | 
| Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL |  | Prior to and one month after the 3rd vaccine dose | 
| Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL |  | Prior to and one month after the 3rd vaccine dose | 
| Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL |  | Prior to and one month after the 3rd vaccine dose | 
| Vaccine response to pertussis toxoid (PT) |  | Prior to 3rd vaccine dose | 
| Evaluation of anti-diphtheria antibody concentrations |  | Prior to 3rd vaccine dose | 
| Anti-poliovirus types 1, 2 and 3 antibody titers |  | Prior to and one month after the 3rd vaccine dose | 
| Occurrence of solicited local injection site symptoms |  | During the solicited follow-up period (Day 0 7) following administration of each vaccine dose | 
| Occurrence of solicited systemic symptoms |  | During the solicited follow-up period (Day 0 7) following administration of each vaccine dose | 
| Occurrence of unsolicited non-serious adverse events (AEs) |  | Within one month (Day 0 30) after each vaccination | 
| Occurrence of any serious adverse events (SAEs) |  | Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose | 
| Vaccine response to pertussis toxoid (PT) |  | One month after the 3rd vaccine dose | 
| Vaccine response to filamentous haemagglutinin (FHA) |  | Prior to 3rd vaccine dose | 
| Vaccine response to filamentous haemagglutinin (FHA) |  | One month after the 3rd vaccine dose | 
| Vaccine response to pertactin (PRN) |  | Prior to 3rd vaccine dose | 
| Vaccine response to pertactin (PRN) |  | One month after the 3rd vaccine dose | 
| Evaluation of anti-diphtheria antibody concentrations |  | One month after the 3rd vaccine dose | 
| Evaluation of anti-tetanus antibody concentrations |  | Prior to 3rd vaccine dose | 
| Evaluation of anti-tetanus antibody concentrations |  | One month after the 3rd vaccine dose | 
| Evaluation of anti-HBs antibody concentrations |  | Prior to 3rd vaccine dose | 
| Evaluation of anti-HBs antibody concentrations |  | One month after the 3rd vaccine dose | 
| Evaluation of anti-PT antibody concentrations |  | Prior to 3rd vaccine dose | 
| Evaluation of anti-PT antibody concentrations |  | One month after the 3rd vaccine dose | 
| Evaluation of anti-FHA antibody concentrations |  | Prior to 3rd vaccine dose | 
| Evaluation of anti-FHA antibody concentrations |  | One month after the 3rd vaccine dose | 
| Evaluation of anti-PRN antibody concentrations |  | Prior to 3rd vaccine dose | 
| Evaluation of anti-PRN antibody concentrations |  | One month after the 3rd vaccine dose | 

 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