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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: Completed Phase 3 study of Hepatitis A, sponsored by GlaxoSmithKline.
NCT00197002 is a Phase 3 study of Hepatitis A that has completed, run by GlaxoSmithKline. The registered enrollment target is 521 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
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
| Field | Value |
|---|---|
| Enrollment Target | 521 participants |
| Start Date | 2003-09-11 |
| Est. Completion | 2006-01-16 |
| Phase | Phase 3 |
What the finished NCT00197002 record still lists
NCT00197002 is an interventional study that assigns participants to a tested intervention. The registered 521 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
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 lists 18 locations in 13 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00197002's enrollment target sits among peer trials
521 717th of 2000 higher than 1,284 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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