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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: Completed Phase 3 study, sponsored by Pfizer.
NCT01352793 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 5,715 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (640% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
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 |
What the finished NCT01352793 record still lists
NCT01352793 is an interventional study that assigns participants to a tested intervention. Its 5,715 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 (640% higher).
The record links to 0 conditions, and to 2 interventions - of which rLP2086 vaccine is the first listed.
NCT01352793 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01352793's enrollment target sits among peer trials
5,715 42nd of 2000 higher than 1,959 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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