Text Size

Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00337818
First received: June 15, 2006
Last updated: November 10, 2011
Last verified: November 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: Open Label;   Primary Purpose: Prevention
Conditions: Papillomavirus Type 16/18 Infection
Cervical Intraepithelial Neoplasia
Intervention: Biological: Cervarix™

  Participant Flow
  Hide Participant Flow

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
Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.

Reporting Groups
  Description
Cervarix New Process Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Cervarix Old Process Group Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Cervarix Young Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.

Participant Flow:   Overall Study
    Cervarix New Process     Cervarix Old Process Group     Cervarix Young  
STARTED     458     154     158  
COMPLETED     169     63     51  
NOT COMPLETED     289     91     107  
Lost to Follow-up                 289                 91                 107  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Cervarix New Process Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Cervarix Old Process Group Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Cervarix Young Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Total Total of all reporting groups

Baseline Measures
    Cervarix New Process     Cervarix Old Process Group     Cervarix Young     Total  
Number of Participants  
[units: participants]
 		  458     154     158     770  
Age  
[units: years]
Mean ± Standard Deviation 		  20.2  ± 2.96     20.3  ± 2.99     12.4  ± 1.37     18.6  ± 4.2  
Gender  
[units: Subjects]
 		       
Female     458     154     158     770  
Male     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies   [ Time Frame: At months 18*, 24, 36 and 48 ]
  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 in Cervical Samples   [ Time Frame: At months 24, 36, and 48 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Measure Description Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame At months 24, 36, and 48  
Safety Issue No  

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.
Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.

Reporting Groups
  Description
Cervarix New Process Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Cervarix Old Process Group Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Cervarix Young Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.

Measured Values
    Cervarix New Process     Cervarix Old Process Group     Cervarix Young  
Number of Participants Analyzed  
[units: participants]
 		  78     27     4  
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples  
[units: EL.U/mL]
Geometric Mean ( 95% Confidence Interval ) 		     
HPV-16 (Month 24) (n= 55, 13, 1)     85.4  
  ( 57.9 to 125.8 )   		  107.5  
  ( 47.5 to 242.8 )   		  198.8  
  ( 198.8 to 198.8 )  
HPV-16 (Month 36) (n= 78, 27, 3)     68.2  
  ( 54.6 to 85.2 )   		  62.1  
  ( 40.8 to 94.7 )   		  63.4  
  ( 4.8 to 845.9 )  
HPV-16 (Month 48) (n=69, 19, 4)     56.2  
  ( 43.4 to 72.8 )   		  94.5  
  ( 50.8 to 175.8 )   		  129.2  
  ( 12.8 to 1305.0 )  
HPV-18 (Month 24) (n= 55, 13, 1)     45.9  
  ( 31.1 to 67.6 )   		  31.9  
  ( 15.8 to 64.4 )   		  107.9  
  ( 107.9 to 107.9 )  
HPV-18 (Month 36) (n= 78, 27, 3)     38.9  
  ( 31.2 to 48.6 )   		  29.6  
  ( 19.8 to 44.2 )   		  19.9  
  ( 1.1 to 362.2 )  
HPV-18 (Month 48) (n= 66, 19, 4)     33.9  
  ( 24.7 to 46.5 )   		  48.8  
  ( 26.4 to 90.0 )   		  97.5  
  ( 38.7 to 245.4 )  

No statistical analysis provided for Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples



3.  Secondary:   Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples   [ Time Frame: At Months 24, 36 and 48 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)   [ Time Frame: Throughout the study period (up to Month 48) ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Reporting SAEs   [ Time Frame: Throughout the study period (up to Month 48) ]
  Show Outcome Measure 5


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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
No text entered.  


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


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00337818     History of Changes
Obsolete Identifiers: NCT00337844, NCT00337857, NCT00338169
Other Study ID Numbers: 107476 (M18), 107477, 107479, 107481
Study First Received: June 15, 2006
Results First Received: November 12, 2009
Last Updated: November 10, 2011
Health Authority: Estonia: The State Agency of Medicine