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Alternate Dosing Schedules Study for HPV Vaccine (ADS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00862810
First received: March 15, 2009
Last updated: November 19, 2014
Last verified: September 2014
Results First Received: September 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Cervical Cancer
Genital Warts
Interventions: Biological: Received HPV vaccine first
Biological: Received concomitant vaccines first

  Participant Flow
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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
  Description
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  
NOT COMPLETED     4     4  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  33     39     72  
Age  
[units: participants]
     
<=18 years     33     39     72  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[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
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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
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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
e-mail: walte002@mc.duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00862810     History of Changes
Other Study ID Numbers: Pro00014388, CDC#U36/CCU319276 CFDA 93.283
Study First Received: March 15, 2009
Results First Received: September 17, 2014
Last Updated: November 19, 2014
Health Authority: United States: Institutional Review Board