Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00258700
First received: November 24, 2005
Last updated: November 3, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age.


Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Meningococcal Serogroup Diseases
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Demonstrate Non-inferiority of Men-C Immune Response of Hib-MenC With Infanrix™-IPV Versus a Licensed Men-C Vaccine With Pediacel™ When Given at 2, 3, 4 m and the Immunogenicity of Hib-MenC When Given as a Booster Dose at 12-15 m

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 1 m after the 3rd dose of primary vaccination: SBA-MenC titre ≥ 1:8 (seroprotection status), anti-PRP concentration ≥ 0.15 µg/ml. 42 d after the booster vaccination: SBA-MenC titre ≥ 1:128, anti-PRP concentration ≥ 1 μg/ml [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antibody levels to all vaccine antigens:1 m post dose 3, prior to & 42 d post booster. After each dose: Solicited (d 0-3, local & general), unsolicited (d 0-30) & MMR specific (d 0-42) symptoms. SAEs (whole study). [ Designated as safety issue: No ]

Enrollment: 478
Study Start Date: February 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). The study will be conducted in two stages. Primary vaccination phase: 3 doses Hib-MenC-TT with Infanrix™-IPV or for the control group a licensed Men-C vaccine with Pediacel™ at 2, 3, 4 months of age; Booster/persistence phase: 1 dose Hib-MenC with Priorix™. 4 blood samples of 3.5ml (5ml for the UK subset) are collected (Study Months 0 & 3, prior to & 42 days after the booster).

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male or female, between, and including, 6 and 12 weeks of age.
  • Born after a gestation period between 36 and 42 weeks
  • Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine), accepted although not mandatory

Exclusion criteria:

  • Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines.
  • History of H. influenzae type b and /or meningococcal serogroup C disease.
  • Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease.
  • 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
  • History of 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: NCT00258700

Locations
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Gdansk, Poland, 80-394
GSK Investigational Site
Kielce, Poland, 25-711
GSK Investigational Site
Krakow, Poland, 31-202
GSK Investigational Site
Leczna, Poland, 21-010
GSK Investigational Site
Lodz, Poland, 91-347
GSK Investigational Site
Poznan, Poland, 6-709
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
GSK Investigational Site
Trzebnica, Poland, 55-100
United Kingdom
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00258700     History of Changes
Other Study ID Numbers: 103974 (primary study), 104056
Study First Received: November 24, 2005
Last Updated: November 3, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014