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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3016 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-31

Study Completion Date

2020-12-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cervarix group

Healthy female Chinese subjects aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.

Safety data collection (following routine vaccination)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.