Back to resultsHuman Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Primary Purpose
Papillomavirus Type 16/18 Infection, Cervical Intraepithelial Neoplasia
Status
Completed
Phase
Phase 3
Locations
Estonia
Study Type
Interventional
Intervention
Cervarix™
Sponsored by
About this trial
This is an interventional prevention trial for Papillomavirus Type 16/18 Infection focused on measuring Non-inferiority, Immunogenicity, HPV Vaccine Consistency
Eligibility Criteria
Inclusion Criteria: A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7). Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent). Exclusion criteria Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cervarix New Process
Cervarix Old Process Group
Cervarix Young/Lot 1 Group
Arm Description
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process.
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the old manufacturing process.
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process (Lot 1).
Outcomes
Primary Outcome Measures
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Secondary Outcome Measures
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
Number of Subjects Reporting SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00337818
Brief Title
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Official Title
A Long-term, Open, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1/AS04 Vaccine in Healthy Female Subjects Vaccinated Either Pre- or Post-menarche in the Primary Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
Detailed Description
Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Type 16/18 Infection, Cervical Intraepithelial Neoplasia
Keywords
Non-inferiority, Immunogenicity, HPV Vaccine Consistency
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
770 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervarix New Process
Arm Type
Experimental
Arm Description
Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process.
Arm Title
Cervarix Old Process Group
Arm Type
Experimental
Arm Description
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the old manufacturing process.
Arm Title
Cervarix Young/Lot 1 Group
Arm Type
Experimental
Arm Description
Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV]) produced with the new manufacturing process (Lot 1).
Intervention Type
Biological
Intervention Name(s)
Cervarix™
Intervention Description
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Primary Outcome Measure Information:
Title
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Description
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
*Data for Month 18 outcome variables were incorporated into the Month 24 analyses.
Time Frame
At months 18*, 24, 36 and 48
Secondary Outcome Measure Information:
Title
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples
Description
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame
At months 24, 36, and 48
Title
Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples
Description
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame
At Months 24, 36 and 48
Title
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Description
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
Time Frame
Throughout the study period (up to Month 48)
Title
Number of Subjects Reporting SAEs
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
Throughout the study period (up to Month 48)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).
Exclusion criteria
Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
1162
Country
Estonia
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.gov/ct/show/NCT00169494
Description
Primary Study
Learn more about this trial
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
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