Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

Phase 4

Terminated

• Conditions: Acellular Pertussis; Diphtheria; Tetanus

• Registration Number: NCT00544271
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study Completion: 2004-01
• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• Male or female children between and including 18 -20 months of age at the time of the vaccination.
• Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
• Written informed consent obtained before study entry from the parents or guardians of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
• Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Occurrence of local injection site reactions (1M after vacc).

Secondary Outcome Measures

Name	Time	Method
Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
SAEs (full study).

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Carlton, Victoria, Australia