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Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250276
First Posted: November 8, 2005
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: January 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Intervention: Biological: Cervarix™

  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
No text entered.

Reporting Groups
  Description
Cervarix Lot1 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Lot2 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Lot3 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    Cervarix Lot1 Group   Cervarix Lot2 Group   Cervarix Lot3 Group   Cervarix Low Group
STARTED   199   198   201   200 
COMPLETED   182   177   182   181 
NOT COMPLETED   17   21   19   19 
Serious Adverse Event                0                0                1                0 
Non-serious Adverse Event                2                0                0                2 
Protocol Violation                0                1                0                0 
Withdrawal by Subject                1                2                3                2 
Migrated/moved from study area                3                0                2                7 
Lost to Follow-up                11                18                13                8 



  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 Lot1 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Lot2 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Lot3 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
   Cervarix Lot1 Group   Cervarix Lot2 Group   Cervarix Lot3 Group   Cervarix Low Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 199   198   201   200   798 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.8  (2.08)   21.8  (2.08)   21.9  (2.00)   22.0  (1.96)   21.88  (2.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      199 100.0%      198 100.0%      201 100.0%      200 100.0%      798 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)   [ Time Frame: At Month 7 ]

2.  Primary:   Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18   [ Time Frame: At Month 7 ]

3.  Secondary:   Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18   [ Time Frame: At Month 2 ]

4.  Secondary:   Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18   [ Time Frame: At Month 2 ]

5.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 7-days (Day 0-6) post-vaccination ]

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

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

8.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-days (Day 0-6) post-vaccination ]

9.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-days (Day 0-6) post-vaccination ]

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

11.  Secondary:   Number of Subjects With Medically Significant Adverse Events (MSAEs)   [ Time Frame: From Month 0 to Month 7 ]

12.  Secondary:   Number of Subjects With (NOCDs)   [ Time Frame: From Month 0 to Month 12 ]

13.  Secondary:   Number of Subjects With MSAEs   [ Time Frame: From Month 0 to Month 12 ]

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

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

16.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Month 0 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
None reported.


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00250276     History of Changes
Other Study ID Numbers: 104772
First Submitted: November 7, 2005
First Posted: November 8, 2005
Results First Submitted: January 31, 2017
Results First Posted: March 17, 2017
Last Update Posted: March 17, 2017