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


Phase 3
15 Years
24 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 a HPV Vaccine (580299) in Healthy Female Subjects


Subjects were aged 10-14 years at the time of entry into the primary study. 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 and/or their parents or legally
acceptable representative (LAR) can and will comply with the requirements of the
protocol should be enrolled in the study.

- A female enrolled in the immunogenicity subset of study 580299-013, who received
three doses of HPV vaccine and participated in the extension study of 580299-013.

- Written informed assent obtained from the subject. For subjects below the legal age
of consent, written informed consent must be 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.

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

- Administration or planned administration of any HPV vaccine, other than the vaccine
administered in study 580299-013.

- Chronic administration of immunosuppressants or other immune-modifying drugs
occurring within the three months preceding study entry.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers

Outcome Description:

Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).

Outcome Time Frame:

at Month 60

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Colombia: INVIMA

Study ID:

111375

NCT ID:

NCT00877877

Start Date:

May 2009

Completion Date:

January 2015

Related Keywords:

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

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