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NCT01461993 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,499
- Enrollment target
NCT01461993 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 2,499 participants.
The verdict
NCT01461993, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,499 participants
- Enrollment target
Study Summary
This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.
Interventions
- BIOLOGICAL Gardasil
- BIOLOGICAL rLP2086 and Gardasil
- BIOLOGICAL rLP2086
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,499 participants |
| Start Date | 2011-09-28 |
| Est. Completion | 2013-07-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01461993
The ClinicalTrials.gov registry entry for NCT01461993 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,499 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gardasil is the first listed.
NCT01461993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01461993 about?
NCT01461993 is a clinical study titled "A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17". This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vacc...
What is the current status of trial NCT01461993?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,499 participants. The study started on 2011-09-28. Estimated completion is 2013-07-06.
What interventions are being tested in trial NCT01461993?
The interventions under investigation include: Gardasil (BIOLOGICAL), rLP2086 and Gardasil (BIOLOGICAL), rLP2086 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01461993?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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