Know Cancer

or
forgot password

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


Phase 3
10 Years
25 Years
Not Enrolling
Female
Papillomavirus Type 16/18 Infection, Cervical Intraepithelial Neoplasia

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

Outcome 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.

Outcome Time Frame:

At months 18*, 24, 36 and 48

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Estonia: The State Agency of Medicine

Study ID:

107476 (M18)

NCT ID:

NCT00337818

Start Date:

June 2006

Completion Date:

January 2009

Related Keywords:

  • Papillomavirus Type 16/18 Infection
  • Cervical Intraepithelial Neoplasia
  • Non-inferiority
  • Immunogenicity
  • HPV Vaccine Consistency
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location