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COMPLETED Phase 3

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

NCT00148941 · View on ClinicalTrials.gov ↗

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.

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

558 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00148941 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00148941?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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