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NCT00197002 · ClinicalTrials.gov registry record · Phase 3

Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

A Phase 3 study of Hepatitis A, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
521
Enrollment target
18
Study locations

NCT00197002 is a Phase 3 study of Hepatitis A that has completed, run by GlaxoSmithKline. The registered enrollment target is 521 participants. The trial reports 18 study locations across 13 states.

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The verdict

NCT00197002, a Phase 3 study of Hepatitis A, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
521 participants
Enrollment target
18
Study locations

Study Summary

This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.

Conditions Studied

Interventions

  • BIOLOGICAL GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)
  • BIOLOGICAL Prevnar™

Study Locations (18)

Kentucky

  • GSK Investigational Site - Bardstown
  • GSK Investigational Site - Louisville

Massachusetts

  • GSK Investigational Site - Boston
  • GSK Investigational Site - Boston

Nevada

  • GSK Investigational Site - Las Vegas
  • GSK Investigational Site - North Las Vegas

Texas

  • GSK Investigational Site - Dallas
  • GSK Investigational Site - San Antonio

Utah

  • GSK Investigational Site - Salt Lake City
  • GSK Investigational Site - Salt Lake City

Colorado

  • GSK Investigational Site - Centennial

Michigan

  • GSK Investigational Site - Kalamazoo

Nebraska

  • GSK Investigational Site - Omaha

Trial Details

FieldValue
Enrollment Target 521 participants
Start Date 2003-09-11
Est. Completion 2006-01-16
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00197002

The ClinicalTrials.gov registry entry for NCT00197002 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 521 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis A appearing as the primary indexed condition, and to 2 interventions - of which GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) is the first listed.

NCT00197002 reports 18 study locations spanning 13 distinct geographic areas - top geographies include Kentucky, Massachusetts, Nevada.

Frequently Asked Questions

What is clinical trial NCT00197002 about?

NCT00197002 is a clinical study titled "Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age". This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.

What is the current status of trial NCT00197002?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 521 participants. The study started on 2003-09-11. Estimated completion is 2006-01-16.

What conditions does trial NCT00197002 study?

This clinical trial studies the following conditions: Hepatitis A.

What interventions are being tested in trial NCT00197002?

The interventions under investigation include: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) (BIOLOGICAL), Prevnar™ (BIOLOGICAL).

Who is sponsoring clinical trial NCT00197002?

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

Where is trial NCT00197002 being conducted?

This trial has 18 study locations across Colorado, Kentucky, Massachusetts, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.