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CompletedNCT00263692Updated Sep 15, 2016

Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety

A Phase 2 interventional study of Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3 in Diphtheria, Acellular Pertussis and Tetanus, sponsored by GlaxoSmithKline. Completed at 15 sites in United States. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-15.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
401
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study summary

The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.

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Conditions studied

  • Diphtheria
  • Acellular Pertussis
  • Tetanus

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03

In context

Diphtheria

265 studies on the registry are indexed under Diphtheria; 16 are open to participants now.

This study's enrollment of 401 is close to the median of 440 across 239 interventional studies indexed under Diphtheria.

Browse Diphtheria studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

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Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy children between and including 4 and 6 years of age.
  • Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
  • Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
  • Administration of immunoglobulins and/or blood products within 3 months prior to vaccination.
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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
401 participants (actual)

Interventions

  • BiologicalProphylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3
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What researchers measure

Primary outcomes

  1. Immunogenicity after vaccination.

Secondary outcomes

  1. Immunogenicity and safety after vaccination.

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Study locations

15 sites
  • GSK Investigational Site
    Jonesboro, Arkansas 72401, United States
  • GSK Investigational Site
    Fountain Valley, California 92708, United States
  • GSK Investigational Site
    Oakland, California 94612, United States
  • GSK Investigational Site
    Torrance, California 90502, United States
  • GSK Investigational Site
    Marietta, Georgia 30062, United States
  • GSK Investigational Site
    Woodstock, Georgia 30188, United States
  • GSK Investigational Site
    Chicago, Illinois 60614, United States
  • GSK Investigational Site
    New Orleans, Louisiana 70128, United States
  • GSK Investigational Site
    Ruston, Louisiana 71270, United States
  • GSK Investigational Site
    Berlin, New Jersey 08009, United States
  • GSK Investigational Site
    Whitehouse Station, New Jersey 08889, United States
  • GSK Investigational Site
    Endwell, New York 13760, United States
  • GSK Investigational Site
    Stony Brook, New York 11794, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15241, United States
  • GSK Investigational Site
    Mechanicsville, Virginia 23111, United States
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References and documents

Publications

  • Black S, Friedland LR, Schuind A, Howe B; GlaxoSmithKline DTaP-IPV Vaccine Study Group. Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years. Vaccine. 2006 Aug 28;24(35-36):6163-71. doi: 10.1016/j.vaccine.2006.04.001. Epub 2006 Apr 21. PubMed 16759769 ↗
  • Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008 Nov;7(9):1309-20. doi: 10.1586/14760584.7.9.1309. PubMed 18980534 ↗

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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00263692
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 9, 2005
Start date
Nov 2002
Primary completion
Sep 2004
Completion
Sep 2004
Last update
Sep 15, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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