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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: Completed Phase 2 study, sponsored by Pfizer.

NCT01461993 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 2,499 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1779% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 2,499 participants
Start Date 2011-09-28
Est. Completion 2013-07-06
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT01461993 record still lists

NCT01461993 is an interventional study that assigns participants to a tested intervention. Its 2,499 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 (1779% higher).

The record links to 0 conditions, and to 3 interventions - of which Gardasil is the first listed.

NCT01461993 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01461993's enrollment target sits among peer trials

2,499 8th of 2000 higher than 1,993 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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Source: ClinicalTrials.gov NCT01461993, the US trial registry maintained by the National Library of Medicine. NCT01461993 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.