Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00426361
First received: January 23, 2007
Last updated: March 14, 2013
Last verified: March 2013
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: Human Papillomavirus Infection
Cervical Intraepithelial Neoplasia
Papillomavirus Vaccines
Interventions: Biological: Boostrix ® Polio
Biological: GSK Biologicals' HPV-16/18 L1 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
No text entered.

Reporting Groups
  Description
Cervarix Group Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Cervarix + Boostrix Polio Group Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Boostrix Polio → Cervarix Group Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.

Participant Flow:   Overall Study
    Cervarix Group     Cervarix + Boostrix Polio Group     Boostrix Polio → Cervarix Group  
STARTED     248     255     248  
COMPLETED     244     250     243  
NOT COMPLETED     4     5     5  
Lost to Follow-up                 3                 2                 5  
Withdrawal by Subject                 1                 3                 0  



  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.
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Reporting Groups
  Description
Cervarix Group Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Cervarix + Boostrix Polio Group Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Boostrix Polio → Cervarix Group Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Total Total of all reporting groups

Baseline Measures
    Cervarix Group     Cervarix + Boostrix Polio Group     Boostrix Polio → Cervarix Group     Total  
Number of Participants  
[units: participants]
  248     255     248     751  
Age  
[units: years]
Mean ± Standard Deviation
       
Active phase (up to Month 7/8)     13.9  ± 2.59     14.0  ± 2.43     13.9  ± 2.47     13.9  ± 2.50  
Safety follow-up (up to Month 12/13)     13.9  ± 2.58     13.9  ± 2.41     13.8  ± 2.46     13.9  ± 2.48  
Gender  
[units: Subjects]
       
Female     248     255     248     751  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Number of Subjects Seroprotected Against Diphtheria and Tetanus   [ Time Frame: One month after vaccination with Boostrix Polio ]

2.  Primary:   Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies   [ Time Frame: One month after vaccination with Boostrix Polio ]

3.  Primary:   Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3   [ Time Frame: One month after vaccination with Boostrix Polio ]

4.  Secondary:   Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course   [ Time Frame: One month post Cervarix Dose 3 (Month 7/8) ]

5.  Secondary:   Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course   [ Time Frame: One month post Dose 1 ]

6.  Secondary:   Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course   [ Time Frame: One month post Cervarix Dose 3 (Month 7/8)] ]

7.  Secondary:   Titers of Anti-diphtheria and Anti-tetanus Antibodies   [ Time Frame: One month after vaccination with Boostrix-Polio ]

8.  Secondary:   Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)   [ Time Frame: One month after vaccination with Boostrix Polio ]

9.  Secondary:   Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers   [ Time Frame: One month after vaccination with Boostrix Polio ]

10.  Secondary:   Number of Subjects With Booster Response to Diphtheria and Tetanus   [ Time Frame: One month after vaccination with Boostrix Polio ]

11.  Secondary:   Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)   [ Time Frame: One month after vaccination with Boostrix Polio ]

12.  Secondary:   Number of Subjects Reporting Solicited Symptoms   [ Time Frame: During the 7-day period (Day 0-6) following each vaccination ]

13.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events   [ Time Frame: During the 30-day period (Day 0-29) following vaccination ]

14.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)   [ Time Frame: During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13) ]

15.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13) ]


  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
No text entered.  


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


Publications:
Schwarz T et al. Co-administration of AS04-adjuvanted HPV-16/18 cervical cancer vaccine with DTPA-IPV in 10-18 year old girls: Month 7 results from a randomized trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00426361     History of Changes
Other Study ID Numbers: 108464
Study First Received: January 23, 2007
Results First Received: November 12, 2009
Last Updated: March 14, 2013
Health Authority: Germany: Paul-Ehrlich-Institut