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NCT00148941 · ClinicalTrials.gov registry record · Phase 3

Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

A Phase 3 study of Diphtheria and Tetanus, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
4,209
Enrollment target
20
Study locations

NCT00148941 is a Phase 3 study of Diphtheria and Tetanus that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,209 participants, above the 1,586-participant average among 15 other Diphtheria trials with a reported enrollment target (165% higher). The trial reports 20 study locations across 2 states.

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The verdict

NCT00148941, a Phase 3 study of Diphtheria and Tetanus, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
4,209 participants
Enrollment target
20
Study locations

Study Summary

The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine \[Infanrix\] and Aventis Pasteur's IPV vaccine \[IPOL\]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.

Conditions Studied

Diphtheria Tetanus Acellular Pertussis

Interventions

  • BIOLOGICAL SB213503 lot 1
  • BIOLOGICAL SB213503 lot 2
  • BIOLOGICAL SB213503 lot 3
  • BIOLOGICAL Infanrix
  • BIOLOGICAL IPOL

Study Locations (20)

California

  • GSK Investigational Site - Antioch
  • GSK Investigational Site - Daly City
  • GSK Investigational Site - Fairfield
  • GSK Investigational Site - Fremont
  • GSK Investigational Site - Fresno
  • GSK Investigational Site - Hayward
  • GSK Investigational Site - Oakland
  • GSK Investigational Site - Pleasanton
  • GSK Investigational Site - Redwood City
  • GSK Investigational Site - Richmond
  • GSK Investigational Site - Roseville
  • GSK Investigational Site - Sacramento
  • GSK Investigational Site - Sacramento
  • GSK Investigational Site - San Francisco
  • GSK Investigational Site - San Jose
  • GSK Investigational Site - San Ramon
  • GSK Investigational Site - Santa Clara
  • GSK Investigational Site - Santa Rosa
  • GSK Investigational Site - Vacaville

Arkansas

  • GSK Investigational Site - Little Rock

Trial Details

FieldValue
Enrollment Target 4,209 participants
Start Date 2005-01-06
Est. Completion 2006-12-04
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00148941

The ClinicalTrials.gov registry entry for NCT00148941 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,209 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,586-participant average among 15 other Diphtheria trials with a reported enrollment target (165% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diphtheria appearing as the primary indexed condition, and to 5 interventions - of which SB213503 lot 1 is the first listed.

NCT00148941 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00148941 about?

NCT00148941 is a clinical study titled "Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines". The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control v...

What is the current status of trial NCT00148941?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,209 participants. The study started on 2005-01-06. Estimated completion is 2006-12-04.

What conditions does trial NCT00148941 study?

This clinical trial studies the following conditions: Diphtheria, Tetanus, Acellular Pertussis.

What interventions are being tested in trial NCT00148941?

The interventions under investigation include: SB213503 lot 1 (BIOLOGICAL), SB213503 lot 2 (BIOLOGICAL), SB213503 lot 3 (BIOLOGICAL), Infanrix (BIOLOGICAL), IPOL (BIOLOGICAL).

Who is sponsoring clinical trial NCT00148941?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00148941 being conducted?

This trial has 20 study locations across Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.