Last updated: 07/17/2024 17:33:09

A Post Marketing Surveillance (PMS) study to monitor the safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine in female Chinese subjects

GSK study ID
207350
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Clinicaltrials.gov ID
NCT03438006
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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)

Timeframe: During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6)

Secondary outcomes:

Number of participants with any, fatal and vaccine related serious AEFIs (across doses)

Timeframe: Throughout the study period (From Day 1 to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24) whichever occured first))

Number of participants with any, grade 3 and vaccine related potential immune mediated diseases (pIMDs) (across doses)

Timeframe: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))

Number of participants reporting pregnancies and outcomes of reported pregnancies

Timeframe: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))

Interventions:
  • Other: Safety data collection (following routine vaccination)
    • Enrollment:
    3016
    Primary completion date:
    2020-03-12
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Qianhui Wu, Mengcen Qian, Sarah Welby, Adrienne Guignard, Dominique Rosillon, Kusuma Gopala, Yuan Xu, Keruo Liu, Yunkun He, Ning Jiang, Qin Tan, Jiamin Xie, Taoying Zhu, Qizhang Wang, Yingzi Pan, Ruikun Zeng, Jie Yang, Xiaoqian Zhao, Man Zhou, Adoración Navarro-Torné, Hongjie Yu, Dorota Borys. Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018-2020. Human vaccines & immunotherapeutics. DOI: 10.1080/21645515.2023.2283912 PMID: 38038626
    Medical condition
    Cervical Intraepithelial Neoplasia
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    May 2018 to December 2020
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    9 - 45 Years
    Accepts healthy volunteers
    Yes
    • 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.
    • Child in care
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Shenzhen, Guangdong, China, 518000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shanghai, China, 200136
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shanghai, China, 200030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chengdu, Sichuan, China, 610000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Changzhou, Jiangsu, China, 213100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Foshan, Guangdong, China, 528000
    Status
    Study Complete
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    Study documents

    Study report synopsis
    Available language(s): English
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    Protocol
    Available language(s): English
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    Statistical analysis plan
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2020-03-12
    Actual study completion date
    2020-03-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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