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

NCT00197275 | Completed Phase 3

• 1 other identifier: 104733
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Tetanus; Hepatitis B; Haemophilus Influenzae Type b; Whole Cell Pertussis; Diphtheria

Keywords

Haemophilus influenzae type b; diphtheria; tetanus; Prophylaxis diphtheria; pertussis; hepatitis B; meningococcal serogroups A & C diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Hib-MenAC mixed with Tritanrix™-HepB BIOLOGICAL

Eligibility Criteria

• Age: 56 Days - 83 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

GSK Investigational Site

Songkhla, 90110, Thailand

Location

Related Publications (1)

• Guignard A, Haguinet F, Wery S, Kerdpanich P. Prevalence and Persistence of Maternal Dengue Neutralizing Antibodies in Infants From Central and Southern Thailand: A Retrospective Cohort Study. Asia Pac J Public Health. 2019 May;31(4):288-295. doi: 10.1177/1010539519853396.

  PMID: 31307216 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Tetanus; Hepatitis B; Haemophilus Infections; Diphtheria; Whooping Cough

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

TH (3)