Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00337818
First received: June 15, 2006
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Papillomavirus Type 16/18 Infection
Cervical Intraepithelial Neoplasia
Biological: Cervarix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: At months 18*, 24, 36 and 48 ] [ Designated as safety issue: No ]

    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 [ Time Frame: At months 24, 36, and 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Months 24, 36 and 48 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Throughout the study period (up to Month 48) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Throughout the study period (up to Month 48) ] [ Designated as safety issue: No ]
    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.


Enrollment: 770
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix New Process
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.
Biological: Cervarix™
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Experimental: Cervarix Old Process Group
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.
Biological: Cervarix™
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Experimental: Cervarix Young/Lot 1 Group
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).
Biological: Cervarix™
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)

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.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337818

Locations
Estonia
GSK Investigational Site
Tallinn, Estonia, 1162
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00337818     History of Changes
Obsolete Identifiers: NCT00337844, NCT00337857, NCT00338169
Other Study ID Numbers: 107476 (M18), 107477, 107479, 107481
Study First Received: June 15, 2006
Results First Received: November 12, 2009
Last Updated: November 10, 2011
Health Authority: Estonia: The State Agency of Medicine

Keywords provided by GlaxoSmithKline:
Non-inferiority
Immunogenicity
HPV Vaccine Consistency

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014