Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00541970
First received: October 9, 2007
Last updated: March 13, 2014
Last verified: June 2013
Results First Received: October 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Interventions: Biological: Cervarix
Drug: 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
The study included two phases, an active vaccination phase (Months 0-7) followed by a safety follow-up phase (up to the end of the study at Month 60).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was run in an open manner for subjects in the groups receiving the Cervarix vaccine on a 3-dose vaccination schedule. For subjects in the group receiving the Cervarix vaccine on a 2-dose vaccination schedule, the study was run in an observer-blind manner until Month 24, and then in an open manner.

Reporting Groups
  Description
Cervarix 1/Placebo Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Cervarix 1/Placebo/Cervarix 1 Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Cervarix 2/Placebo/Cervarix 2 Group Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Cervarix 2 Group Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.

Participant Flow for 7 periods

Period 1:   Month 7
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group  
STARTED     240     241     240     239  
COMPLETED     231     228     229     234  
NOT COMPLETED     9     13     11     5  
Protocol Violation                 9                 13                 11                 5  

Period 2:   Month 12
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group  
STARTED     240     241     240     239  
COMPLETED     228     219     219     223  
NOT COMPLETED     12     22     21     16  
Adverse Event                 0                 1                 1                 1  
Protocol Violation                 12                 21                 20                 15  

Period 3:   Month 18
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group  
STARTED     240     241     240     239  
COMPLETED     226     217     215     222  
NOT COMPLETED     14     24     25     17  
Adverse Event                 0                 1                 1                 1  
Protocol Violation                 14                 23                 24                 16  

Period 4:   Month 24
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group  
STARTED     240     241     240     239  
COMPLETED     211     209     208     217  
NOT COMPLETED     29     32     32     22  
Adverse Event                 0                 1                 1                 1  
Protocol Violation                 29                 31                 31                 21  

Period 5:   Month 36
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group  
STARTED     240     241     240     239  
COMPLETED     179     175     174     179  
NOT COMPLETED     61     66     66     60  
Protocol Violation                 61                 66                 66                 60  

Period 6:   Month 48
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group  
STARTED     240     241     240     239  
COMPLETED     169     168     167     164  
NOT COMPLETED     71     73     73     75  
Withdrawal by Subject                 2                 4                 4                 2  
Unspecified                 3                 1                 1                 0  
Lost to Follow-up                 66                 68                 68                 73  

Period 7:   Month 60
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group  
STARTED     240     241     240     239  
COMPLETED     162     164     158     167  
NOT COMPLETED     78     77     82     72  
Protocol Violation                 78                 77                 82                 72  



  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 1/Placebo Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Cervarix 1/Placebo/Cervarix 1 Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Cervarix 2/Placebo/Cervarix 2 Group Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Cervarix 2 Group Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
    Cervarix 1/Placebo Group     Cervarix 1/Placebo/Cervarix 1 Group     Cervarix 2/Placebo/Cervarix 2 Group     Cervarix 2 Group     Total  
Number of Participants  
[units: participants]
  240     241     240     239     960  
Age  
[units: Years]
Mean ± Standard Deviation
  17.1  ± 4.30     17.2  ± 4.30     17.3  ± 4.25     17.2  ± 4.38     17.2  ± 4.31  
Gender  
[units: Subjects]
         
Female     240     241     240     239     960  
Male     0     0     0     0     0  



  Outcome Measures
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1.  Primary:   Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies   [ Time Frame: One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7). ]

2.  Primary:   Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms   [ Time Frame: Within 7 days (Day 0-6) after vaccination. ]

3.  Primary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: Within 7 days (Day 0-6) after vaccination. ]

4.  Secondary:   Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .   [ Time Frame: At Month 3, 1 month after the second dose of vaccine or placebo ]

5.  Secondary:   Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At Month 7, 1 month after the last dose of vaccine or placebo. ]

6.  Secondary:   Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase. ]

7.  Secondary:   Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At Month 7, 1 month after the last dose of vaccine or placebo. ]

8.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

9.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

10.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

11.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

12.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

13.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

14.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

15.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

16.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

17.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

18.  Secondary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Month 7 (M7) ]

19.  Secondary:   Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)   [ Time Frame: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase. ]

20.  Secondary:   Number of Subjects With Pregnancy Outcomes.   [ Time Frame: From Month 0 to Month 48. ]

21.  Secondary:   Number of Subjects With Pregnancy Outcomes.   [ Time Frame: Throughout the study period, from Month 0 to Month 60. ]

22.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).   [ Time Frame: Within 30 days (Day 0-29) after vaccination. ]

23.  Secondary:   Number of Subjects With Medically Significant Conditions (MSCs).   [ Time Frame: From Month 0 to Month 7. ]

24.  Secondary:   Number of Subjects With Medically Significant Conditions (MSCs).   [ Time Frame: From Month 0 to Month 48. ]

25.  Secondary:   Number of Subjects With Medically Significant Conditions (MSCs).   [ Time Frame: Throughout the study period, from Month 0 to Month 60. ]

26.  Secondary:   Number of Subjects With New Onset of Autoimmune Diseases (NOADs)   [ Time Frame: From Month 0 to Month 7. ]

27.  Secondary:   Number of Subjects With New Onset of Autoimune Diseases (NOADs)   [ Time Frame: From Month 0 to Month 48. ]

28.  Secondary:   Number of Subjects With New Onset of Autoimmune Diseases (NOADs)   [ Time Frame: Throughout the study period, from Month 0 to Month 60. ]

29.  Secondary:   Number of Subjects With New Onset of Chronic Diseases (NOCDs)   [ Time Frame: From Month 0 to Month 7. ]

30.  Secondary:   Number of Subjects With New Onset of Chronic Diseases (NOCDs)   [ Time Frame: From Month 0 to Month 48. ]

31.  Secondary:   Number of Subjects With New Onset of Chronic Diseases (NOCDs)   [ Time Frame: Throughout the study period, from Month 0 to Month 60. ]

32.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs).   [ Time Frame: From Month 0 to Month 7. ]

33.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs).   [ Time Frame: From Month 0 to Month 48. ]

34.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Throughout the study period, from Month 0 to Month 60. ]

35.  Secondary:   Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At Month 60 of the safety follow-up phase ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No

36.  Secondary:   Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)   [ Time Frame: At Month 60 of the safety follow-up phase ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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
If appropriate, describe significant limitations of the trial. Examples: Early termination leading to small number of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data.  


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


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Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00541970     History of Changes
Other Study ID Numbers: 110659
Study First Received: October 9, 2007
Results First Received: October 18, 2012
Last Updated: March 13, 2014
Health Authority: Canada: Health Canada