Status:
COMPLETED
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
9-45 years
Brief Summary
The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused ...
Eligibility Criteria
Inclusion
- Any Chinese female subject aged between 9 and 45 years, at the time of first vaccination dose, who received voluntary vaccination.
- Subjects for whom the investigator believed that they or their parent(s)/LAR(s) could and complied with the requirements mentioned in the protocol (e.g., return for the subsequent dose of vaccination and follow-up visits) were included in the study.
- Written informed consent was obtained from the subject. For subjects who were below the legal age of consent, written informed consent were obtained from the parent(s)/LAR(s) of the subject and informed assent were obtained from the subject according to EC requirement as well as local law.
Exclusion
- • Child in care
Key Trial Info
Start Date :
May 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
3016 Patients enrolled
Trial Details
Trial ID
NCT03438006
Start Date
May 31 2018
End Date
December 3 2020
Last Update
September 8 2021
Active Locations (7)
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1
GSK Investigational Site
Foshan, Guangdong, China, 528000
2
GSK Investigational Site
Shenzhen, Guangdong, China, 518000
3
GSK Investigational Site
Shenzhen, Guangdong, China, 518020
4
GSK Investigational Site
Changzhou, Jiangsu, China, 213100