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Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects


Phase 3
20 Years
60 Years
Open (Enrolling)
Female
Human Papillomavirus Infection

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Trial Information

Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects


Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No
vaccine will be administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this
record. Please refer to the records mentioned in the respective outcome measure titles.


Inclusion Criteria:



- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol.

- A female who enrolled in NCT00332475 and received three doses of GSK 580299 vaccine.

- Written informed consent obtained from the subject.

Exclusion Criteria:

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

- Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs occurring less than three months
prior to blood sampling.

- 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).

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

- Administration or planned administration of any HPV vaccine, other than the three
doses of HPV-16/18 vaccine administered in NCT00332475 study.

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:

Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum

Outcome Description:

Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).

Outcome Time Frame:

At Year 5 and 6

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

112772

NCT ID:

NCT00947115

Start Date:

September 2009

Completion Date:

February 2015

Related Keywords:

  • Human Papillomavirus Infection
  • Cervical cancer
  • HPV vaccine
  • Warts
  • Papillomavirus Infections

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