Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
17+ years
Phase:
PHASE3
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-0...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2018
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03355820
Start Date
February 28 2018
End Date
June 29 2018
Last Update
November 19 2020
Active Locations (1)
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1
GSK Investigational Site
Taizhou, Jiangsu, China, 225300