Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197275
First received: September 19, 2005
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.


Condition Intervention Phase
Healthy Subjects
Infant
Meningitis, Meningococcal
Meningitis, Haemophilus
Biological: Hib-MenAC mixed with Tritanrix™-HepB
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Demonstrate Lot-to-lot Consistency of Final Production Method of GSK Biologicals' Hib-MenAC Vaccine Mixed Extemporaneously With Tritanrix™-HepB & Demonstrate Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Healthy Infants at 2,4&6 Months

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus

Secondary Outcome Measures:
  • Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs

Estimated Enrollment: 800
Study Start Date: February 2006
Intervention Details:
    Biological: Hib-MenAC mixed with Tritanrix™-HepB
    Other Name: Hib-MenAC mixed with Tritanrix™-HepB
Detailed Description:

The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject

  Eligibility

Ages Eligible for Study:   56 Days to 83 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • healthy male or female, between, and including, 56 and 83 days of age.
  • Born after a gestation period between 36 and 42 weeks
  • Birth dose of hepatitis B vaccine within the first 72 hours of life

Exclusion criteria:

  • planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period.
  • Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
  • History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal 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: NCT00197275

Locations
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Khon Kaen, Thailand, 40002
GSK Investigational Site
Songkla, Thailand, 90110
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00197275     History of Changes
Other Study ID Numbers: 104733
Study First Received: September 19, 2005
Last Updated: September 29, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by GlaxoSmithKline:
Haemophilus influenzae type b
diphtheria
tetanus
Prophylaxis diphtheria
pertussis
hepatitis B
meningococcal serogroups A & C diseases

Additional relevant MeSH terms:
Meningitis
Meningitis, Haemophilus
Meningitis, Meningococcal
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
Meningococcal Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on April 17, 2014