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. Identifier: NCT00862810
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : September 25, 2014
Last Update Posted : November 20, 2014
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Received HPV Vaccine First Received HPV vaccine first
Received Concomitant Vaccines First Received Concomitant Vaccines First

Participant Flow:   Overall Study
    Received HPV Vaccine First   Received Concomitant Vaccines First
STARTED   33   39 
COMPLETED   29   35 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Received HPV Vaccine First Received HPV vaccine first
Received Concomitant Vaccines First Received concomitant vaccines first
Total Total of all reporting groups

Baseline Measures
   Received HPV Vaccine First   Received Concomitant Vaccines First   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   39   72 
[Units: Participants]
<=18 years   33   39   72 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Participants]
Female   33   39   72 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   33   39   72 

  Outcome Measures

1.  Primary:   Pain Following HPV Vaccine   [ Time Frame: 10 minutes following vaccination ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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:  
Name/Title: Emmanuel Walter MD, MPH
Organization: Duke University Health System
phone: 919-620-5346

Responsible Party: Duke University 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