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Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00344032
First received: June 23, 2006
Last updated: March 17, 2011
Last verified: March 2011
History of Changes
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Papillomavirus Infection
Interventions: Biological: Placebo
Biological: HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)

  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 Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Placebo Subjects who received 3 doses of Placebo (at 0, 1, 6 months).

Participant Flow:   Overall Study
    Cervarix     Placebo  
STARTED     176     178  
COMPLETED     162     168  
NOT COMPLETED     14     10  
Adverse Event                 0                 1  
Withdrawal by Subject                 6                 2  
Lost to Follow-up                 4                 6  
Physician Decision                 4                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Cervarix Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Placebo Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Total Total of all reporting groups

Baseline Measures
    Cervarix     Placebo     Total  
Number of Participants  
[units: participants]
 		  176     178     354  
Age  
[units: Years]
Mean ± Standard Deviation 		  28.5  ± 4.70     28.5  ± 4.97     28.5  ± 4.83  
Gender  
[units: Subjects]
 		     
Female     176     178     354  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At Month 7 ]
  Show Outcome Measure 1

2.  Secondary:   Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At Months 0 and 7 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Reporting Solicited Symptoms   [ Time Frame: During the 7 days (Days 0 - 6) after each vaccination ]
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4.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: Within 30 days (Days 0 - 29) after each vaccination ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)   [ Time Frame: Throughout the study period (up to Month 7) ]
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6.  Secondary:   Number of Subjects Reporting Serious Adverse Events   [ Time Frame: Throughout the study period (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:
Bhatla N et al. (2010) Immunogenicity and safety of human papillomavirus- 16/18 AS04- adjuvanted cervical cancer vaccine in healthy Indian women. J Obstet Gynaecol Res. 36(1): 123-132.

Publications automatically indexed to this study:


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00344032     History of Changes
Other Study ID Numbers: 104479
Study First Received: June 23, 2006
Results First Received: November 12, 2009
Last Updated: March 17, 2011
Health Authority: India: Drugs Controller General of India (DCGI)