Infections, Meningococcal
Conditions
Keywords
Haemophilus Influenzae type b/Meningococcal vaccine, Prophylaxis meningococcal serogroup C disease, Hib diseases
Brief summary
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
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.
Interventions
BIOLOGICALMenC-TT
BIOLOGICALHib-MenC-TT
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 16 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 filamentous haemagglutinin (FHA) | Prior to 3rd vaccine dose |
| Vaccine response to pertactin (PRN) | Prior to 3rd vaccine dose |
| Evaluation of anti-tetanus antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-HBs antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-PT antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-FHA antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-PRN antibody concentrations | Prior to 3rd vaccine dose |
Outcome results
None listed