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

NCT ID: NCT03355820

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2018-06-29

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.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Immune response; Cervarix; Persistence; Chinese; Human papillomavirus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HPV Group

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.

Group Type: EXPERIMENTAL

Blood sampling for antibody determination

Intervention Type: PROCEDURE

In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (\~5 mL) will be taken from all the subjects, at Day 1.

Interventions

Blood sampling for antibody determination

In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (\~5 mL) will be taken from all the subjects, at Day 1.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Taizhou, Jiangsu, China

Countries

China

References

Hu Y, Zhang X, He Y, Ma Z, Xie Y, Lu X, Xu Y, Zhang Y, Jiang Y, Xiao H, Struyf F, Folschweiller N, Jiang J, Poncelet S, Karkada N, Jastorff A, Borys D. Long-term persistence of immune response to the AS04-adjuvanted HPV-16/18 vaccine in Chinese girls aged 9-17 years: Results from an 8-9-year follow-up phase III open-label study. Asia Pac J Clin Oncol. 2020 Dec;16(6):392-399. doi: 10.1111/ajco.13398. Epub 2020 Aug 11.

Reference Type: BACKGROUND

PMID: 32780946 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-000255-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

207347

Identifier Type: -

Identifier Source: org_study_id