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

Tetanus Clinical Trial

Official title:

Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00544271
• Other study ID #: 263855/035
• Status: Terminated
• Phase: Phase 4
• First received: October 15, 2007
• Last updated: September 6, 2016
• Start date: May 2003
• Est. completion date: January 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 720
• Est. completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 20 Months

Eligibility

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

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

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

Biological:
• INFANRIX

• BOOSTRIX

• HAVRIX

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Carlton	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Primary	Occurrence of local injection site reactions (1M after vacc).
Secondary	Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
Secondary	Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
Secondary	SAEs (full study).

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