Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03438006
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2018-02-13
Brief Title:
A Post Marketing Surveillance PMS Study to Monitor the Safety of GlaxoSmithKline GSK Biologicals Human Papillomavirus HPV Vaccine in Female Chinese Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Prospective Multi-centre Post Marketing Surveillance PMS Cohort Study to Monitor the Safety of GlaxoSmithKline GSK Biologicals Human Papillomavirus HPV-1618 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
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 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
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 23 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None