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

NCT03438006 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3016

Last updated 2021-09-08

Study results available
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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.

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
9 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2020-12-03
Completion
2020-12-03

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438006 on ClinicalTrials.gov