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Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849381
First received: February 19, 2009
Last updated: September 4, 2014
Last verified: August 2014
Results First Received: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Intervention: Biological: GSK580299, GSK Biological's HPV vaccine

  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
Subjects enrolled in this study were previously enrolled in the Control Group in the primary study (NCT00122681), where they had received Hepatitis A vaccination.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Results from one study center where compliance issues were discovered were presented both separately from the entire study cohort, as well as included in it. Out of the 1239 subjects enrolled in this study, 2 did not receive vaccination and were hence eliminated from the study.

Reporting Groups
  Description
Cervarix Group Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.

Participant Flow:   Overall Study
    Cervarix Group  
STARTED     1237 [1]
COMPLETED     1092 [2]
NOT COMPLETED     145  
Adverse Event                 1  
Lost to Follow-up                 129  
Protocol Violation                 5  
Withdrawal by Subject                 6  
Unspecified                 4  
[1] Out of the subjects who started, 243 were enrolled at the center having compliance issues.
[2] Out of the subjects who completed, 167 were enrolled at the center having compliance issues.



  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.
No text entered.

Reporting Groups
  Description
Cervarix Group Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.

Baseline Measures
    Cervarix Group  
Number of Participants  
[units: participants]
  1237  
Age  
[units: Years]
Mean ± Standard Deviation
  28.2  ± 1.47  
Age [1]
[units: Years]
Mean ± Standard Deviation
  28.7  ± 1.59  
Gender  
[units: Subjects]
 
Female     1237  
Male     0  
Gender [1]
[units: Participants]
 
Female     243  
Male     0  
[1] Non-compliant center population



  Outcome Measures
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1.  Primary:   Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (up to Month 12) ]

2.  Primary:   Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)   [ Time Frame: During the entire study period (up to Month 12) ]

3.  Primary:   Number of Subjects With Pregnancies and Pregnancy Outcomes   [ Time Frame: During the entire study period (up to Month 12) ]


  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
No text entered.


  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.


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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849381     History of Changes
Other Study ID Numbers: 111758
Study First Received: February 19, 2009
Results First Received: November 27, 2013
Last Updated: September 4, 2014
Health Authority: Taiwan: Department of Health
Brazil: ANVISA
Thailand: Royal Thai Army Medical Department