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

Hepatitis B Clinical Trial

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 and 6 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197275
• Other study ID #: 104733
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2005
• Last updated: October 6, 2016
• Start date: February 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 56 Days to 83 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis
• Hepatitis B
• Tetanus
• Whole Cell Pertussis
• Whooping Cough

Intervention

Biological:
• Hib-MenAC mixed with Tritanrix™-HepB

Locations

Country	Name	City	State
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Khon Kaen
Thailand	GSK Investigational Site	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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