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Completed

NCT Number: NCT00135486

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

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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Key information

Conditions

Infections, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

8 week–16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MenC-TT

Biological

Hib-MenC-TT

Biological

Other names: MenC-TT

Primary outcomes

  1. 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

  2. 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

  3. 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

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

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

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

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

  6. 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

  7. 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

  8. Vaccine response to pertussis toxoid (PT)

    Time frame: Prior to 3rd vaccine dose

  9. Evaluation of anti-diphtheria antibody concentrations

    Time frame: Prior to 3rd vaccine dose

  10. Anti-poliovirus types 1, 2 and 3 antibody titers

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

  11. Occurrence of solicited local injection site symptoms

    Time frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose

  12. Occurrence of solicited systemic symptoms

    Time frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose

  13. Occurrence of unsolicited non-serious adverse events (AEs)

    Time frame: Within one month (Day 0 30) after each vaccination

  14. Occurrence of any serious adverse events (SAEs)

    Time frame: Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose

  15. Vaccine response to pertussis toxoid (PT)

    Time frame: One month after the 3rd vaccine dose

  16. Vaccine response to filamentous haemagglutinin (FHA)

    Time frame: Prior to 3rd vaccine dose

  17. Vaccine response to filamentous haemagglutinin (FHA)

    Time frame: One month after the 3rd vaccine dose

  18. Vaccine response to pertactin (PRN)

    Time frame: Prior to 3rd vaccine dose

  19. Vaccine response to pertactin (PRN)

    Time frame: One month after the 3rd vaccine dose

  20. Evaluation of anti-diphtheria antibody concentrations

    Time frame: One month after the 3rd vaccine dose

  21. Evaluation of anti-tetanus antibody concentrations

    Time frame: Prior to 3rd vaccine dose

  22. Evaluation of anti-tetanus antibody concentrations

    Time frame: One month after the 3rd vaccine dose

  23. Evaluation of anti-HBs antibody concentrations

    Time frame: Prior to 3rd vaccine dose

  24. Evaluation of anti-HBs antibody concentrations

    Time frame: One month after the 3rd vaccine dose

  25. Evaluation of anti-PT antibody concentrations

    Time frame: Prior to 3rd vaccine dose

  26. Evaluation of anti-PT antibody concentrations

    Time frame: One month after the 3rd vaccine dose

  27. Evaluation of anti-FHA antibody concentrations

    Time frame: Prior to 3rd vaccine dose

  28. Evaluation of anti-FHA antibody concentrations

    Time frame: One month after the 3rd vaccine dose

  29. Evaluation of anti-PRN antibody concentrations

    Time frame: Prior to 3rd vaccine dose

  30. Evaluation of anti-PRN antibody concentrations

    Time frame: One month after the 3rd vaccine dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Aug 26, 2005
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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