A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects

CompletedOBSERVATIONAL
Enrollment

3,016

Participants

Timeline

Start Date

May 31, 2018

Primary Completion Date

December 3, 2020

Study Completion Date

December 3, 2020

Conditions
Cervical Intraepithelial Neoplasia
Interventions
OTHER

Safety data collection (following routine vaccination)

"This study assessed the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine when administered routinely according to the Prescribing Information in female Chinese subjects aged between 9 and 45 years.~The intervention consisted in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine was administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes were collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician."

Trial Locations (7)

200030

GSK Investigational Site, Shanghai

200136

GSK Investigational Site, Shanghai

213100

GSK Investigational Site, Changzhou

518000

GSK Investigational Site, Shenzhen

518020

GSK Investigational Site, Shenzhen

528000

GSK Investigational Site, Foshan

610000

GSK Investigational Site, Chengdu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03438006 - A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects | Biotech Hunter | Biotech Hunter