Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03355820•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

17 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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.

Locations (1)

GSK Investigational Site

Taizhou, Jiangsu, China

Key Dates

Start Date

February 28, 2018

Primary Completion Date

June 29, 2018

Completion Date

June 29, 2018

Last Updated

November 19, 2020

Enrollment

228

ACTUAL participants

Conditions

Cervical Intraepithelial Neoplasia

Interventions

Blood sampling for antibody determination

PROCEDURE

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

NCT04712851

Cervical Intraepithelial NeoplasiaCervical Squamous Cell Carcinoma In Situ+1 more

View study

RECRUITINGPHASE4

Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

NCT05266898

Papillomavirus VaccinesHuman Immunodeficiency Virus+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection

Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia

Effectiveness of Cervical Screening in HPV Vaccinated Women