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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135486
First received: August 25, 2005
Last updated: November 23, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Meningitis, Haemophilus
Biological: MenC-TT
Biological: Hib-MenC-TT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups

Secondary Outcome Measures:
  • Prior to dose 1, 1 m post doses 2, 3: anti-PRP
  • Prior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN
  • Solicited (days [d] 0–7), unsolicited (up to 30 d) adverse events (AEs) after each dose
  • Serious adverse events (SAEs)

Estimated Enrollment: 500
Study Start Date: March 2002
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

Ages Eligible for Study:   8 Weeks to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135486

Locations
Germany
GSK Clinical Trials Call Center
Mainz, Germany
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00135486     History of Changes
Other Study ID Numbers: 711202/001
Study First Received: August 25, 2005
Last Updated: November 23, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Prophylaxis meningococcal serogroup C disease, Hib diseases
Haemophilus Influenzae type b/Meningococcal vaccine

Additional relevant MeSH terms:
Meningitis
Meningitis, Haemophilus
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Haemophilus Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 22, 2014