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

NCT00544271 | Terminated Phase 4

• 1 other identifier: 263855/035
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Acellular Pertussis; Tetanus; Diphtheria

Keywords

BOOSTRIX; INFANRIX

Outcome Measures

Primary Outcomes (2)

• Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)

• Occurrence of local injection site reactions (1M after vacc).

Secondary Outcomes (3)

• 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).

Interventions

INFANRIX BIOLOGICAL

BOOSTRIX BIOLOGICAL

HAVRIX BIOLOGICAL

Also known as: INFANRIX, BOOSTRIX

Eligibility Criteria

• Age: 18 Months - 20 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Carlton, Victoria, 3053, Australia

Location

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; Diphtheria

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines; Boostrix; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit; Viral Hepatitis Vaccines; Viral Vaccines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: May 1, 2003
• Study Completion: January 1, 2004
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)