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A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00485732
First received: June 12, 2007
Last updated: April 7, 2011
Last verified: February 2011
History of Changes
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Human Papillomavirus (HPV) Infection
Associated Cervical Neoplasia
Papillomavirus Vaccines
Interventions: Biological: HPV-16/18 VLP/AS04 vaccine (Cervarix TM)
Biological: Placebo

  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 HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Placebo Group Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.

Participant Flow:   Overall Study
    Cervarix Group     Placebo Group  
STARTED     149     76  
COMPLETED     141     67  
NOT COMPLETED     8     9  
Protocol Violation                 1                 3  
Withdrawal by Subject                 5                 4  
Lost to Follow-up                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Cervarix Group Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Placebo Group Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
Total Total of all reporting groups

Baseline Measures
    Cervarix Group     Placebo Group     Total  
Number of Participants  
[units: participants]
 		  149     76     225  
Age  
[units: years]
Mean ± Standard Deviation 		  22.0  ± 2.24     21.9  ± 2.63     22.0  ± 2.37  
Gender  
[units: subjects]
 		     
Female     149     76     225  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies   [ Time Frame: One month post Dose 3 (Month 7) ]
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2.  Secondary:   Anti-HPV-16 and Anti-HPV-18 Antibody Titres   [ Time Frame: Before vaccination (PRE) and one month post Dose 3 (Month 7) ]
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3.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ]
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4.  Secondary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ]
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5.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: During the 30-day (Days 0-29) period following each vaccination ]
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6.  Secondary:   Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions   [ Time Frame: From Day 0 up to Month 7 ]
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7.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: From Day 0 up to Month 7 ]
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8.  Secondary:   Number of Subjects With Pregnancies and Their Outcome   [ Time Frame: from Day 0 up to Month 7 ]
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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


Publications:


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00485732     History of Changes
Other Study ID Numbers: 107291
Study First Received: June 12, 2007
Results First Received: November 12, 2009
Last Updated: April 7, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)