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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00337818
Other study ID # 107476 (M18)
Secondary ID 1074771074791074
Status Completed
Phase Phase 3
First received June 15, 2006
Last updated May 25, 2017
Start date June 2006
Est. completion date January 2009

Study information

Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00337844
  • NCT00337857
  • NCT00338169

Recruitment information / eligibility

Status Completed
Enrollment 770
Est. completion date January 2009
Est. primary completion date June 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 25 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Cervarix™
Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)

Locations

Country Name City State
Estonia GSK Investigational Site Tallinn

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Estonia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
At months 18*, 24, 36 and 48
Secondary 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. At months 24, 36, and 48
Secondary 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. At Months 24, 36 and 48
Secondary 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. Throughout the study period (up to Month 48)
Secondary 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. Throughout the study period (up to Month 48)
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Completed NCT00316706 - Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine Phase 3
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Completed NCT03293628 - Comparing Two Techniques of Haemostasis After Cervical Conization Phase 2
Recruiting NCT05266898 - Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV Phase 4
Completed NCT02481414 - A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions Phase 2
Completed NCT02247999 - Improving Cervical Cancer Screening Among HIV-Infected Women in India
Recruiting NCT04646954 - DNA Methylation Testing for the Screening of Uterine Cervical Lesion Phase 3
Recruiting NCT04650711 - Immunohistochemical Staining of p16 for the Screening of Cervical Cancer Phase 2
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