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A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013


Phase 3
10 Years
14 Years
Not Enrolling
Female
Cervical Intraepithelial Neoplasia, Papillomavirus Infection

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Trial Information

A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013


Inclusion Criteria:



- A female who enrolled in the immunological subset of the 580299-013 study, received
the three doses of vaccine/control according to the treatment allocation and
completed the 580299-013 study.

- Written informed assent obtained from the subject and written informed consent
obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria:

- 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).

- Use of any investigational or non-registered product (drug or vaccine) or planned use
during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs
occurring less than 3 months prior to blood sampling.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding blood sampling.

Type of Study:

Interventional

Study Design:

Allocation: Non-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).

Outcome Time Frame:

At 18, 24, 36 and 48 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Germany: Land Authority for Health and Social Issues

Study ID:

104896 (month 18 FU)

NCT ID:

NCT00316706

Start Date:

October 2005

Completion Date:

January 2009

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Papillomavirus Infection
  • Prophylaxis HPV-16/18 infections and cervical neoplasia
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ
  • Papillomavirus Infections

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