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Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00947115
First received: July 16, 2009
Last updated: April 14, 2016
Last verified: March 2016
Results First Received: February 10, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Interventions: Procedure: Blood sampling
Procedure: Cervico-vaginal secretion (CVS) samples

  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
Out of the 525 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 524. However, not all subjects came to all study visits, hence the actual starting numbers varied depending on the rate of return.

Reporting Groups
  Description
Cervarix 15-25 Years Group Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Cervarix 26-45 Years Group Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Cervarix 46-55 Years Group Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)

Participant Flow for 7 periods

Period 1:   Year 5 (Month 60)
    Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group
STARTED   153   184   170 
COMPLETED   153   184   170 
NOT COMPLETED   0   0   0 

Period 2:   Year 6 (Month 72)
    Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group
STARTED   147   177   164 
COMPLETED   147   177   164 
NOT COMPLETED   0   0   0 

Period 3:   Year 7 (Month 84)
    Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group
STARTED   149   165   160 
COMPLETED   149   165   160 
NOT COMPLETED   0   0   0 

Period 4:   Year 8 (Month 96)
    Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group
STARTED   137   152   141 
COMPLETED   137   152   141 
NOT COMPLETED   0   0   0 

Period 5:   Year 9 (Month 108)
    Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group
STARTED   146   180   157 
COMPLETED   146   180   157 
NOT COMPLETED   0   0   0 

Period 6:   Year 10 (Month 120)
    Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group
STARTED   142   172   156 
COMPLETED   142   172   156 
NOT COMPLETED   0   0   0 

Period 7:   Year 0 (Month 0) - Year 10 (Month 120)
    Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group
STARTED   159   194   171 
COMPLETED   142   172   156 
NOT COMPLETED   17   22   15 
Missed reporting interval                3                4                2 
Physician Decision                0                2                0 
Death                0                1                1 
Migrated from study area                2                0                0 
Withdrawal by Subject                1                3                4 
Lost to Follow-up                11                12                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.
Some subjects who came for the Year 5 timepoint did not return for the Year 6, 7, 8 or 9 timepoints, hence the numbers of subjects starting each year (based on the actual rate of return for visits) do not correspond to the ones of the previous years.

Reporting Groups
  Description
Cervarix 15-25 Years Group Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Cervarix 26-45 Years Group Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Cervarix 46-55 Years Group Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Total Total of all reporting groups

Baseline Measures
   Cervarix 15-25 Years Group   Cervarix 26-45 Years Group   Cervarix 46-55 Years Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   194   171   524 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 25.7  (2.82)   41.0  (6.02)   54.4  (3.15)   40.9  (12.22) 
[1] Data for Year 5
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 26.6  (2.85)   41.8  (6.05)   55.4  (3.20)   41.8  (12.28) 
[1] Data for year 6
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 27.5  (2.78)   42.9  (5.96)   56.4  (3.23)   42.6  (12.42) 
[1] Data for Year 7
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 28.3  (2.8)   44.0  (6.0)   57.6  (2.9)   35.6  (12.57) 
[1] Data for Year 8
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 29.5  (2.8)   45.2  (6.0)   58.6  (2.9)   44.8  (12.32) 
[1] Data for Year 9
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 30.6  (2.8)   46.1  (6.0)   59.6  (2.8)   45.9  (12.3) 
[1] Data for Year 10
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 30.6  (2.8)   46.1  (6.0)   59.6  (2.8)   45.8  (12.3) 
[1] Data for Year 0 - Year 10
Gender [1] 
[Units: Subjects]
       
Female   153   184   170   507 
Male   0   0   0   0 
[1] Data for Year 5
Gender [1] 
[Units: Subjects]
       
Female   147   177   164   488 
Male   0   0   0   0 
[1] Data for Year 6
Gender [1] 
[Units: Subjects]
       
Female   149   165   160   474 
Male   0   0   0   0 
[1] Data for Year 7
Gender [1] 
[Units: Subjects]
       
Female   137   152   141   430 
Male   0   0   0   0 
[1] Data for Year 8
Gender [1] 
[Units: Subjects]
       
Female   146   180   157   483 
Male   0   0   0   0 
[1] Data for Year 9
Gender [1] 
[Units: Subjects]
       
Female   142   172   156   470 
Male   0   0   0   0 
[1] Data for Year 10
Gender [1] 
[Units: Subjects]
       
Female   159   194   171   524 
Male   0   0   0   0 
[1] Data for Year 0 - Year 10


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum   [ Time Frame: At Year 5, 6 and 7 ]

2.  Primary:   Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum   [ Time Frame: At Years 8, 9 and 10 ]

3.  Primary:   Number of Seroconverted Subjects.   [ Time Frame: At Year 5, 6 and 7 ]

4.  Primary:   Number of Seroconverted Subjects.   [ Time Frame: At Years 8, 9 and 10 ]

5.  Secondary:   Total Immunoglobulin G (IgG) Antibody Titers in Serum   [ Time Frame: At Year 5, 6 and 7 ]

6.  Secondary:   Total Immunoglobulin G (IgG) Antibody Titers in Serum   [ Time Frame: At Years 8, 9 and 10 ]

7.  Secondary:   Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)   [ Time Frame: At Year 5 and Year 6 ]

8.  Secondary:   Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)   [ Time Frame: At Years 7, 8, 9, 10 ]

9.  Secondary:   Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS   [ Time Frame: At Year 5 and Year 6 ]

10.  Secondary:   Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS   [ Time Frame: At Years 7, 8, 9, 10 ]

11.  Secondary:   Total Immunoglobulin G (IgG) Antibody Titers in Serum   [ Time Frame: At Year 5, 6 and 7 ]

12.  Secondary:   Total Immunoglobulin G (IgG) Antibody Titers in Serum   [ Time Frame: At Years 8, 9 and 10 ]

13.  Secondary:   Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).   [ Time Frame: From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5) ]

14.  Secondary:   Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).   [ Time Frame: From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit ]

15.  Secondary:   Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).   [ Time Frame: From Month 72 (Year 6) visit to Month 84 (Year 7) visit ]

16.  Secondary:   Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).   [ Time Frame: From Month 84 (Year 7) to the Month 96 (Year 8) visit ]

17.  Secondary:   Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).   [ Time Frame: From Month 96 (Year 8) to the Month 108 (Year 9) visit ]

18.  Secondary:   Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication)   [ Time Frame: From Month 108 (Year 9) to the Month 120 (Year 10) visit ]

19.  Secondary:   Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).   [ Time Frame: From Year 0 up to Year 10 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00947115     History of Changes
Other Study ID Numbers: 112772
Study First Received: July 16, 2009
Results First Received: February 10, 2011
Last Updated: April 14, 2016
Health Authority: Germany: Paul-Ehrlich-Institut