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NCT00578175 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,851
- Enrollment target
NCT00578175: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00578175 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,851 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1292% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578175, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,851 participants
- Enrollment target
Study Summary
The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.
Primary Outcome
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Interventions
- BIOLOGICAL Havrix®
- BIOLOGICAL Prevnar®
- BIOLOGICAL Priorix-Tetra™ (MMRV vaccine 208136)
- BIOLOGICAL ProQuad®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,851 participants |
| Start Date | 2007-11-20 |
| Est. Completion | 2009-03-17 |
| Phase | Phase 2 |
What the finished NCT00578175 record still lists
NCT00578175 is an interventional study that assigns participants to a tested intervention. Its 1,851 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1292% higher).
The record links to 0 conditions, and to 4 interventions - of which Havrix® is the first listed.
NCT00578175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00578175 about?
NCT00578175 is a clinical study titled "Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age". The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.
What is the current status of trial NCT00578175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,851 participants. The study started on 2007-11-20. Estimated completion is 2009-03-17.
What interventions are being tested in trial NCT00578175?
The interventions under investigation include: Havrix® (BIOLOGICAL), Prevnar® (BIOLOGICAL), Priorix-Tetra™ (MMRV vaccine 208136) (BIOLOGICAL), ProQuad® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00578175?
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 NCT00578175's enrollment target sits among peer trials
1,851 10th of 2000 higher than 1,991 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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