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Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00811798
First received: December 18, 2008
Last updated: September 8, 2011
Last verified: September 2011
History of Changes
Results First Received: September 8, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HPV-16/18 Infections and Associated Cervical Neoplasia.
Papillomavirus Vaccines
Intervention: Biological: Cervarix

  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
Cervarix Group Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.

Participant Flow:   Overall Study
    Cervarix Group  
STARTED     92  
COMPLETED     92  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.

Baseline Measures
    Cervarix Group  
Number of Participants  
[units: participants]
 		  92  
Age  
[units: Years]
Mean ± Standard Deviation 		  30.8  ± 4.14  
Gender  
[units: Subjects]
 		 
Female     92  
Male     0  



  Outcome Measures

1.  Primary:   Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.   [ Time Frame: During the entire study period (Day 0 up to the telephone contact at Month 12). ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00811798     History of Changes
Other Study ID Numbers: 111712
Study First Received: December 18, 2008
Results First Received: September 8, 2011
Last Updated: September 8, 2011
Health Authority: Hong Kong: Department of Health