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
228
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
207347
Secondary IDs
2017-000255-50
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
October 2020