Clinical trial NCT00135486: Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Keywords: Haemophilus Influenzae type b/Meningococcal vaccine
Prophylaxis meningococcal serogroup C disease, Hib diseases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
timeFrame: Prior to and one month after the 3rd vaccine dose
measure: Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
timeFrame: Prior to and one month after the 3rd vaccine dose
measure: 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
measure: 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
measure: Vaccine response to pertussis toxoid (PT)
timeFrame: Prior to 3rd vaccine dose
measure: Evaluation of anti-diphtheria antibody concentrations
timeFrame: Prior to 3rd vaccine dose
measure: Anti-poliovirus types 1, 2 and 3 antibody titers
timeFrame: Prior to and one month after the 3rd vaccine dose
measure: Occurrence of solicited local injection site symptoms
timeFrame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
measure: Occurrence of solicited systemic symptoms
timeFrame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
measure: Occurrence of unsolicited non-serious adverse events (AEs)
timeFrame: Within one month (Day 0 30) after each vaccination
measure: 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
measure: Vaccine response to pertussis toxoid (PT)
timeFrame: One month after the 3rd vaccine dose
measure: Vaccine response to filamentous haemagglutinin (FHA)
timeFrame: Prior to 3rd vaccine dose
measure: Vaccine response to filamentous haemagglutinin (FHA)
timeFrame: One month after the 3rd vaccine dose
measure: Vaccine response to pertactin (PRN)
timeFrame: Prior to 3rd vaccine dose
measure: Vaccine response to pertactin (PRN)
timeFrame: One month after the 3rd vaccine dose
measure: Evaluation of anti-diphtheria antibody concentrations
timeFrame: One month after the 3rd vaccine dose
measure: Evaluation of anti-tetanus antibody concentrations
timeFrame: Prior to 3rd vaccine dose
measure: Evaluation of anti-tetanus antibody concentrations
timeFrame: One month after the 3rd vaccine dose
measure: Evaluation of anti-HBs antibody concentrations
timeFrame: Prior to 3rd vaccine dose
measure: Evaluation of anti-HBs antibody concentrations
timeFrame: One month after the 3rd vaccine dose
measure: Evaluation of anti-PT antibody concentrations
timeFrame: Prior to 3rd vaccine dose
measure: Evaluation of anti-PT antibody concentrations
timeFrame: One month after the 3rd vaccine dose
measure: Evaluation of anti-FHA antibody concentrations
timeFrame: Prior to 3rd vaccine dose
measure: Evaluation of anti-FHA antibody concentrations
timeFrame: One month after the 3rd vaccine dose
measure: Evaluation of anti-PRN antibody concentrations
timeFrame: Prior to 3rd vaccine dose
measure: Evaluation of anti-PRN antibody concentrations
timeFrame: One month after the 3rd vaccine dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schmitt HJ, Maechler G, Habermehl P, Knuf M, Saenger R, Begg N, Boutriau D. Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine. Clin Vaccine Immunol. 2007 Apr;14(4):426-34. doi: 10.1128/CVI.00377-06. Epub 2007 Feb 7.