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

GlaxoSmithKline500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Conditions

Infections, Meningococcal

Interventions

MenC-TTBIOLOGICAL

Hib-MenC-TTBIOLOGICAL

Eligibility

Sex: ALLMin age: 8 WeeksMax age: 16 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers

Time frame: 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

Time frame: 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

Time frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses

Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA

Time frame: Prior to and one month after the 3rd vaccine dose

Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL

Time frame: Prior to and one month after the 3rd vaccine dose

Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL

Time frame: Prior to and one month after the 3rd vaccine dose

Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL

Time frame: Prior to and one month after the 3rd vaccine dose

Vaccine response to pertussis toxoid (PT)

Time frame: Prior to 3rd vaccine dose

Evaluation of anti-diphtheria antibody concentrations

Time frame: Prior to 3rd vaccine dose

Anti-poliovirus types 1, 2 and 3 antibody titers

Data from ClinicalTrials.gov

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