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NCT01352793 · ClinicalTrials.gov registry record · Phase 3
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,715
- Enrollment target
NCT01352793 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 5,715 participants.
The verdict
NCT01352793, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,715 participants
- Enrollment target
Study Summary
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.
Interventions
- BIOLOGICAL rLP2086 vaccine
- BIOLOGICAL control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,715 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01352793
The ClinicalTrials.gov registry entry for NCT01352793 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 5,715 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 2 interventions - of which rLP2086 vaccine is the first listed.
NCT01352793 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01352793 about?
NCT01352793 is a clinical study titled "A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years". A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after...
What is the current status of trial NCT01352793?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,715 participants. The study started on 2012-11. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01352793?
The interventions under investigation include: rLP2086 vaccine (BIOLOGICAL), control (BIOLOGICAL).
Who is sponsoring clinical trial NCT01352793?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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