Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00197015 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,474
- Enrollment target
NCT00197015: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00197015 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,474 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00197015, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,474 participants
- Enrollment target
Study Summary
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).
Interventions
- BIOLOGICAL Havrix®
- BIOLOGICAL M-M-R®II
- BIOLOGICAL VARIVAX®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,474 participants |
| Start Date | 2003-10-06 |
| Est. Completion | 2009-06-09 |
| Phase | Phase 3 |
What the finished NCT00197015 record still lists
NCT00197015 is an interventional study that assigns participants to a tested intervention. Its 1,474 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% higher).
The record links to 0 conditions, and to 3 interventions - of which Havrix® is the first listed.
NCT00197015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00197015 about?
NCT00197015 is a clinical study titled "Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children". This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age. The Protocol Posting has been updated in order t...
What is the current status of trial NCT00197015?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,474 participants. The study started on 2003-10-06. Estimated completion is 2009-06-09.
What interventions are being tested in trial NCT00197015?
The interventions under investigation include: Havrix® (BIOLOGICAL), M-M-R®II (BIOLOGICAL), VARIVAX® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00197015?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00197015's enrollment target sits among peer trials
1,474 163rd of 2000 higher than 1,838 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05869552 · 1,485 participants · NA
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care
- NCT03936361 · 1,456 participants · Phase 3
Statins In Intracerbral Hemorrhage
- NCT06782347 · 1,454 participants · NA
Activating SilverSneakers Benefits for Seniors With Osteoarthritis
- NCT04566328 · 1,450 participants · Phase 3
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI