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Alternate Dosing Schedules Study for HPV Vaccine (ADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862810
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : September 25, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Cervical Cancer
Genital Warts
Interventions Biological: Received HPV vaccine first
Biological: Received concomitant vaccines first
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Received HPV Vaccine First Received Concomitant Vaccines First
Hide Arm/Group Description Received HPV vaccine first Received Concomitant Vaccines First
Period Title: Overall Study
Started 33 39
Completed 29 35
Not Completed 4 4
Arm/Group Title Received HPV Vaccine First Received Concomitant Vaccines First Total
Hide Arm/Group Description Received HPV vaccine first Received concomitant vaccines first Total of all reporting groups
Overall Number of Baseline Participants 33 39 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 39 participants 72 participants
<=18 years
33
 100.0%
39
 100.0%
72
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 39 participants 72 participants
Female
33
 100.0%
39
 100.0%
72
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 39 participants 72 participants
33 39 72
1.Primary Outcome
Title Pain Following HPV Vaccine
Hide Description

Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.

The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.

Time Frame 10 minutes following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Received HPV Vaccine First Received Concomitant Vaccines First
Hide Arm/Group Description:
Received HPV vaccine first
Received concomitant vaccines first
Overall Number of Participants Analyzed 33 39
Measure Type: Number
Unit of Measure: participants
17 32
Time Frame Monitored post injection for 10 minutes
Adverse Event Reporting Description Adverse events only reported for randomized subjects
 
Arm/Group Title Received HPV Vaccine First Received Concomitant Vaccines First
Hide Arm/Group Description Received HPV vaccine first Received concomitant vaccines first
All-Cause Mortality
Received HPV Vaccine First Received Concomitant Vaccines First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Received HPV Vaccine First Received Concomitant Vaccines First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Received HPV Vaccine First Received Concomitant Vaccines First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/39 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emmanuel Walter MD, MPH
Organization: Duke University Health System
Phone: 919-620-5346
EMail: walte002@mc.duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00862810     History of Changes
Other Study ID Numbers: Pro00014388
CDC#U36/CCU319276 CFDA 93.283
First Submitted: March 15, 2009
First Posted: March 17, 2009
Results First Submitted: September 17, 2014
Results First Posted: September 25, 2014
Last Update Posted: November 20, 2014