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

Brief Title

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

Official Title

Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects From the HPV-058 Study

Brief Summary

      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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study

Secondary Outcome

 Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies

Condition

Cervical Intraepithelial Neoplasia

Intervention

Blood sampling for antibody determination

Study Arms / Comparison Groups

 HPV 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

February 28, 2018

Completion Date

June 29, 2018

Primary Completion Date

June 29, 2018

Eligibility Criteria

        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.

Gender

Female

Ages

17 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

GSK Clinical Trials, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03355820

Organization ID

Secondary IDs

2017-000255-50

Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline

Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline

Verification Date

October 2020