Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00937950
First received: July 2, 2009
Last updated: February 26, 2015
Last verified: January 2015
Results First Received: January 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Intervention: Procedure: Gynaecological follow-up

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of the 2022 subjects enrolled for this study, 19 were excluded from the Total Vaccinated cohort for reasons of non-eligibility, hence only 2003 started the study.

Reporting Groups
  Description
Cervarix Group Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.

Participant Flow:   Overall Study
    Cervarix Group  
STARTED     2003  
COMPLETED     1787  
NOT COMPLETED     216  
Withdrawal by Subject                 23  
Migrated/moved from study area                 27  
Lost to Follow-up                 144  
Missing confirmed                 4  
Others                 18  



  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 vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.

Baseline Measures
    Cervarix Group  
Number of Participants  
[units: participants]
  2003  
Age  
[units: Years]
Mean ± Standard Deviation
  24.3  ± 3.06  
Gender  
[units: Subjects]
 
Female     2003  
Male     0  



  Outcome Measures
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1.  Primary:   Number of Subjects With HPV DNA in Cervical Samples by HCII   [ Time Frame: At Months 12, 24, 36, 48 ]

2.  Primary:   Number of Subjects With Colposcopy Referral and Colposcopy Adequacy   [ Time Frame: At Months 12, 24, 36, 48 ]

3.  Primary:   Number of Subjects With Cervical Cytology   [ Time Frame: At Months 12, 24, 36, 48 ]

4.  Primary:   Number of Subjects With Cervical Biopsy Results   [ Time Frame: At Month 12 ]

5.  Primary:   Number of Subjects With Cervical Biopsy Results   [ Time Frame: At Month 24 ]

6.  Primary:   Number of Subjects With Cervical Biopsy Results   [ Time Frame: At Month 36 ]

7.  Primary:   Number of Subjects With Cervical Biopsy Results   [ Time Frame: At Month 48 ]

8.  Primary:   Number of Subjects With Treatment Referrals by Treatment Type   [ Time Frame: At Month 12 ]

9.  Primary:   Number of Subjects With Treatment Referrals by Treatment Type   [ Time Frame: At Month 24 ]

10.  Primary:   Number of Subjects With Treatment Referrals by Treatment Type   [ Time Frame: At Month 36 ]

11.  Primary:   Number of Subjects With Treatment Referrals by Treatment Type   [ Time Frame: At Month 48 ]

12.  Primary:   Number of Subjects With AEs or SAEs Leading to Withdrawal   [ Time Frame: Up to Month 48 ]

13.  Primary:   Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.   [ Time Frame: Up to Month 48 ]


  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 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: NCT00937950     History of Changes
Other Study ID Numbers: 112024
Study First Received: July 2, 2009
Results First Received: January 8, 2015
Last Updated: February 26, 2015
Health Authority: Finland: Finnish Medicines Agency
Spain: Agencia Española del Medicamento y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: FAGG
Mexico: Ministry of Health - Secretaria de Salud - Comisión de Autorización Sanitaria - Comisión Federal para la Protección cotnra riesgos de salud
Canada: Biologics and Genetic Therapies Directorate (BGTD)
Taiwan: Department of Health
Thailand: The Ethical Review Committee for Research in Human Subjects, Ministry of Public health
Brazil: ANVISA
Philippines: Bureau of Food and Drugs
Italy: Comitato Etico Provinciale di Modena, Policlinico di Modena Azienda Ospedaliera
Germany: Paul-Ehrlich-Institut
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration