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