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TerminatedNCT00544271Updated Sep 7, 2016

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

A Phase 4 interventional study of INFANRIX and BOOSTRIX in Acellular Pertussis, Tetanus and Diphtheria, sponsored by GlaxoSmithKline. Terminated at 1 site in Australia. Open to participants aged 18 Months to 20 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-07.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
18 Months to 20 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Acellular Pertussis
  • Tetanus
  • Diphtheria

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Keywords

  • BOOSTRIX
  • INFANRIX
03

In context

Tetanus

206 studies on the registry are indexed under Tetanus; 22 are open to participants now.

This study's enrollment of 720 is above the median of 400 across 178 interventional studies indexed under Tetanus.

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Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 20 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
720 participants (actual)

Interventions

  • BiologicalINFANRIX
  • BiologicalBOOSTRIX
  • BiologicalHAVRIX

    Also known as: INFANRIX, BOOSTRIX

06

What researchers measure

Primary outcomes

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

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

Secondary outcomes

  1. Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),

  2. Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),

  3. SAEs (full study).

07

Study locations

1 site
  • GSK Investigational Site
    Carlton, Victoria 3053, Australia
08

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00544271
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 16, 2007
Start date
May 2003
Completion
Jan 2004
Last update
Sep 7, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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