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NCT02280642 · ClinicalTrials.gov registry record
Alternate Dosing Schedules Study for HPV Vaccine (ADS)
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 331
- Enrollment target
NCT02280642 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 331 participants.
The verdict
NCT02280642 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 331 participants
- Enrollment target
Study Summary
The purpose of this study was to determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This was a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. Immune responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended. In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised. Please note: This record refers only to the observational portion of the study. Please refer to NCT00862810 for the results of the randomized portion of the study.
Interventions
- BIOLOGICAL Both 2nd and 3rd doses on time
- BIOLOGICAL 2nd dose late and 3rd dose on time
- BIOLOGICAL 2nd dose on time and 3rd dose late
- BIOLOGICAL Both doses late
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02280642
The ClinicalTrials.gov registry entry for NCT02280642 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Both 2nd and 3rd doses on time is the first listed.
NCT02280642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02280642 about?
NCT02280642 is a clinical study titled "Alternate Dosing Schedules Study for HPV Vaccine (ADS)". The purpose of this study was to determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3...
What is the current status of trial NCT02280642?
This trial is currently completed. The enrollment target is 331 participants. The study started on 2009-03. Estimated completion is 2012-09.
What interventions are being tested in trial NCT02280642?
The interventions under investigation include: Both 2nd and 3rd doses on time (BIOLOGICAL), 2nd dose late and 3rd dose on time (BIOLOGICAL), 2nd dose on time and 3rd dose late (BIOLOGICAL), Both doses late (BIOLOGICAL).
Who is sponsoring clinical trial NCT02280642?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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