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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.

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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

FieldValue
Enrollment Target 5,715 participants
Start Date 2012-11
Est. Completion 2014-09
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.