Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Papillomavirus

Treatments: Biological: Cervarix; Procedure: Blood sampling; Procedure: Collection of cervical specimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518336

109625 (Other Identifier)

109616 (Y7)

109624 (Other Identifier)

Details and patient eligibility

About

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Full description

In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.

Enrollment: 433 patients

Sex: Female

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• Subjects who participated in study 580299-007.
• Written informed consent obtained from the subject prior to enrollment.

Exclusion criteria

• Use or planned use of any investigational or non-registered product other than the study vaccine.
• Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator.
• Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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433 participants in 2 patient groups, including a placebo group

Cervarix Group

Experimental group

Description:

Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.

Treatment:

Procedure: Collection of cervical specimen

Biological: Cervarix

Procedure: Blood sampling

Placebo Group

Placebo Comparator group

Description:

Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.

Treatment:

Procedure: Collection of cervical specimen

Procedure: Blood sampling