Lot-to-Lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-Inferiority vs Tritanrix™-HepB/Hiberix™ in Infants - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00197275

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

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Meningitis Tetanus

U.S. FDA Resources

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

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:	GSK ( Study Director )
Study ID Numbers:	104733
Study First Received:	September 19, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00197275 History of Changes
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by GlaxoSmithKline:

Prophylaxis diphtheria
diphtheria
tetanus
pertussis

hepatitis B
Haemophilus influenzae type b
meningococcal serogroups A & C diseases

Study placed in the following topic categories:

Haemophilus Infections
Bacterial Infections
Meningitis, Bacterial
Haemophilus Influenzae
Meningitis, Meningococcal
Whooping Cough
Central Nervous System Diseases
Meningococcal Infection
Healthy
Diphtheria

Tetanus
Gram-Negative Bacterial Infections
Meningitis
Hepatitis
Central Nervous System Infections
Meningococcal Infections
Influenza, Human
Hepatitis B
Meningitis, Haemophilus
Neisseriaceae Infections

Additional relevant MeSH terms:

Bacterial Infections
Haemophilus Infections
Pasteurellaceae Infections
Nervous System Diseases
Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases

Meningitis
Gram-Negative Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Central Nervous System Bacterial Infections
Meningitis, Haemophilus
Neisseriaceae Infections

ClinicalTrials.gov processed this record on September 03, 2009