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  
Number of Participants  
[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)  
Age [2]
[units: Years]
Mean (Standard Deviation)
  26.6  (2.85)     41.8  (6.05)     55.4  (3.20)     41.8  (12.28)  
Age [3]
[units: Years]
Mean (Standard Deviation)
  27.5  (2.78)     42.9  (5.96)     56.4  (3.23)     42.6  (12.42)  
Age [4]
[units: Years]
Mean (Standard Deviation)
  28.3  (2.8)     44.0  (6.0)     57.6  (2.9)     35.6  (12.57)  
Age [5]
[units: Years]
Mean (Standard Deviation)
  29.5  (2.8)     45.2  (6.0)     58.6  (2.9)     44.8  (12.32)  
Age [6]
[units: Years]
Mean (Standard Deviation)
  30.6  (2.8)     46.1  (6.0)     59.6  (2.8)     45.9  (12.3)  
Age [7]
[units: Years]
Mean (Standard Deviation)
  30.6  (2.8)     46.1  (6.0)     59.6  (2.8)     45.8  (12.3)  
Gender [1]
[units: Subjects]
       
Female     153     184     170     507  
Male     0     0     0     0  
Gender [2]
[units: Subjects]
       
Female     147     177     164     488  
Male     0     0     0     0  
Gender [3]
[units: Subjects]
       
Female     149     165     160     474  
Male     0     0     0     0  
Gender [4]
[units: Subjects]
       
Female     137     152     141     430  
Male     0     0     0     0  
Gender [5]
[units: Subjects]
       
Female     146     180     157     483  
Male     0     0     0     0  
Gender [6]
[units: Subjects]
       
Female     142     172     156     470  
Male     0     0     0     0  
Gender [7]
[units: Subjects]
       
Female     159     194     171     524  
Male     0     0     0     0  
[1] Data for Year 5
[2] Data for year 6
[3] Data for Year 7
[4] Data for Year 8
[5] Data for Year 9
[6] Data for Year 10
[7] 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