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Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00578227
First received: December 20, 2007
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
Results First Received: November 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Human Papillomavirus (HPV) Infection
Papillomavirus Vaccines
Interventions: Biological: Cervarix™
Biological: Twinrix ™ Paediatric

  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
Although the total number of enrolled subjects for this study was 814, one subject did not receive any study vaccine and was therefore not considered as started in the 'Participant Flow' section.

Reporting Groups
  Description
Cervarix™ & Twinrix™ Group Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Cervarix™ Group Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Twinrix™ Group Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).

Participant Flow:   Overall Study
    Cervarix™ & Twinrix™ Group     Cervarix™ Group     Twinrix™ Group  
STARTED     272     270     271  
COMPLETED     267     268     267  
NOT COMPLETED     5     2     4  
Lost to Follow-up                 0                 1                 1  
Withdrawal by Subject                 5                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Cervarix™ & Twinrix™ Group Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Cervarix™ Group Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Twinrix™ Group Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Total Total of all reporting groups

Baseline Measures
    Cervarix™ & Twinrix™ Group     Cervarix™ Group     Twinrix™ Group     Total  
Number of Participants  
[units: participants]
 		  272     270     271     813  
Age  
[units: years]
Mean ± Standard Deviation 		  11.2  ± 2.04     11.2  ± 2.02     11.2  ± 1.99     11.2  ± 2.01  
Gender  
[units: subjects]
 		       
Female     272     270     271     813  
Male     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies   [ Time Frame: At Month 7 ]
  Show Outcome Measure 1

2.  Primary:   Anti-Heptatis A (HAV) Antibody Titers.   [ Time Frame: At Month 7 ]
  Show Outcome Measure 2

3.  Primary:   Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies   [ Time Frame: At Month 7 ]
  Show Outcome Measure 3

4.  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: At Month 7 ]
  Show Outcome Measure 4

5.  Primary:   Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers   [ Time Frame: At Month 7 ]
  Show Outcome Measure 5

6.  Secondary:   Anti-HBs Antibody Titers   [ Time Frame: At Month 7 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Seroconverted for Anti-HBs Antibodies   [ Time Frame: At month 7 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years   [ Time Frame: At Month 7 ]
  Show Outcome Measure 8

9.  Secondary:   Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years   [ Time Frame: At Month 7 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Subjects Seroconverted for Anti-HAV Antibodies   [ Time Frame: One month after the second dose of vaccine ]
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11.  Secondary:   Anti-HAV Antibody Titers   [ Time Frame: One month after the second dose of vaccine ]
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12.  Secondary:   Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies   [ Time Frame: One month after the second dose of vaccine ]
  Show Outcome Measure 12

13.  Secondary:   Anti-HBs Antibody Titers   [ Time Frame: One month after the second dose of vaccine ]
  Show Outcome Measure 13

14.  Secondary:   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 after the second dose of vaccine ]
  Show Outcome Measure 14

15.  Secondary:   Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers   [ Time Frame: One month after the second dose of vaccine ]
  Show Outcome Measure 15

16.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: During the 7-day period (Day 0-6) following vaccination ]
  Show Outcome Measure 16

17.  Secondary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: During the 7-day period following vaccination ]
  Show Outcome Measure 17

18.  Secondary:   Number of Subjects Reporting Medically Significant Conditions   [ Time Frame: Throughout the active phase of the study (up to Month 7) ]
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19.  Secondary:   Number of Subjects Reporting Medically Significant Conditions   [ Time Frame: Throughout the safety follow-up (from Month 7 up to Month 12) ]
  Show Outcome Measure 19

20.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events   [ Time Frame: During the 30-day period following any vaccination ]
  Show Outcome Measure 20

21.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: Throughout the study (up to Month 12) ]
  Show Outcome Measure 21


  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
No text entered.  


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00578227     History of Changes
Other Study ID Numbers: 110886
Study First Received: December 20, 2007
Results First Received: November 27, 2009
Last Updated: February 7, 2013
Health Authority: Hungary: Országos Gyógyszerészeti Intézet
Canada: Health Canada
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency