A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Procedure: Blood sampling for antibody determination

Study type: Interventional

Funder types: Industry

Identifiers

NCT03355820

2017-000255-50 (EudraCT Number)

207347

Details and patient eligibility

About

The purpose of this study is to evaluate the persistence of immune response in subjects who received the HPV-16/18 vaccine, seven to eight years after the last dose of primary vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.

Enrollment: 228 patients

Sex: Female

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects/subject's parents/legally acceptable representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject or subject's parents/LAR(s) prior to performing any study specific procedure.
• Written informed assent obtained from the subjects below the legal age of consent.
• Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine which may have an impact on the study objectives) during the period starting 30 days (Day 29 to Day 1) before the study visit.
• Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
• Previous vaccination against HPV outside the HPV-058 study.
• Subjects with contraindications related to blood draw such as blood disorders and anticoagulants use.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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228 participants in 1 patient group

HPV Group

Experimental group

Description:

Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.

Treatment:

Procedure: Blood sampling for antibody determination