Brief Title
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects
Official Title
A Prospective, Multi-centre Post Marketing Surveillance (PMS) Cohort Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 L1 VLP AS04 Vaccine in Female Chinese Subjects Aged Between 9 and 45 Years, When Administered According to the Prescribing Information (PI) as Per Routine Practice.
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 by HPV types 16 and 18. The vaccine was approved by National Drug
Administration of China (CNDA), in July 2016.
As per the CNDA commitment, this study collected data regarding the safety of the vaccine,
related information on potential immune-mediated diseases (pIMDs); which are diseases that
could affect the immune system, and the effect on pregnancy outcomes (POs) including birth
defects in the newborn.
Cervarix was approved for use in females between 9-25 years of age, for the prevention of
cervical cancer, cervical intraepithelial neoplasia grade 1 (CIN1), cervical intraepithelial
neoplasia grade 2, grade 3 (CIN 2/3) and adenocarcinoma in situ caused by high-risk human
papillomavirus (HR-HPV) types 16 and 18.
In May 2018, Cervarix was also approved for use in women of age up to 45 years.
The exposed set (ES) comprised 3013 subjects, who were vaccinated with Cervarix, on a
voluntary basis, as per standard practice. The study collected information on any adverse
event following immunisation, pIMDs, POs and congenital anomalies.
Study Type
Observational
Primary Outcome
Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Secondary Outcome
Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses)
Condition
Cervical Intraepithelial Neoplasia
Intervention
Safety data collection (following routine vaccination)
Study Arms / Comparison Groups
Cervarix group
Description: Healthy female Chinese subjects aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
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
Other
Estimated Enrollment
3016
Start Date
May 31, 2018
Completion Date
December 3, 2020
Primary Completion Date
December 3, 2020
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
• Child in care
Gender
Female
Ages
9 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
GSK Clinical Trials, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03438006
Organization ID
207350
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
August 2021