Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01277042
First received: January 13, 2011
Last updated: October 4, 2013
Last verified: September 2013
Results First Received: September 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Interventions: Biological: GSK580299 (CervarixTM)
Biological: Engerix-BTM

  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
The study comprised a Primary Vaccination Phase from Day 0 to Month 7, followed by a Long-Term Safety Follow-up Phase, up to Month 12.

Reporting Groups
  Description
Cervarix Group Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Engerix Group Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Participant Flow:   Overall Study
    Cervarix Group     Engerix Group  
STARTED     606     606  
COMPLETED     598     601  
NOT COMPLETED     8     5  
Adverse Event                 4                 3  
Lost to Follow-up                 2                 2  
Withdrawal by Subject                 2                 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.
No text entered.

Reporting Groups
  Description
Cervarix Group Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Engerix Group Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Total Total of all reporting groups

Baseline Measures
    Cervarix Group     Engerix Group     Total  
Number of Participants  
[units: participants]
  606     606     1212  
Age  
[units: Years]
Mean ± Standard Deviation
  35.8  ± 4.92     35.6  ± 5.06     35.7  ± 4.99  
Gender  
[units: Subjects]
     
Female     606     606     1212  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18   [ Time Frame: One month after third vaccination (Month 7) ]

2.  Secondary:   Number of Subjects Seropositive Against HPV-16 and HPV-18   [ Time Frame: Before vaccination (Month 0) and one month after third vaccination (Month 7) ]

3.  Secondary:   Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies   [ Time Frame: Before vaccination (Month 0) and one month after third vaccination (Month 7) ]

4.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 7 days (Days 0 – 6) after any vaccination ]

5.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7 days (Days 0 – 6) after any vaccination ]

6.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)   [ Time Frame: Throughout the study (from Month 0 up to Month 12) ]

7.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: Within 30 days (Days 0 – 29) after any vaccination ]

8.  Secondary:   Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)   [ Time Frame: Throughout the study (from Month 0 up to Month 12) ]

9.  Secondary:   Number of Subjects With Outcome of Pregnancies   [ Time Frame: Throughout the study (from Month 0 up to Month 12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01277042     History of Changes
Other Study ID Numbers: 114590
Study First Received: January 13, 2011
Results First Received: September 6, 2012
Last Updated: October 4, 2013
Health Authority: China: Jiangsu Center for Disease Control and Prevention