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

Overview

The purpose of this prospective, multi-centre, PMS cohort study is 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 will collect 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) will comprise of approximately 3000 subjects, who will be vaccinated with Cervarix, on a voluntary basis, as per standard practice. The study will collect information on any adverse event following immunisation, pIMDs, POs and congenital anomalies.

Full Title of Study: “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.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 3, 2020

Interventions

  • Other: Safety data collection (following routine vaccination)
    • This study assesses 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 consists in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine is administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes will be collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with medically attended adverse events following immunisation (AEFIs)
    • Time Frame: During the 30-day period (Day 1-30), following each immunisation with Cervarix.
    • An adverse event following immunization (AEFI) is defined as any untoward medical occurrence in a subject which follows immunisation, whether or not considered related to the vaccine. An AEFI can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a vaccine. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. Medically attended AEFIs are defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended AEFI leads to hospitalisation (or meets any other serious AEFI criteria), it will be reported as serious AEFI.

Secondary Measures

  • Number of subjects with serious adverse events following immunisation (AEFIs)
    • Time Frame: During the period starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occurs first.
    • A serious AEFI is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a subject.
  • Number of subjects with potential immune-mediated diseases (pIMDs)
    • Time Frame: During the period starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occurs first.
    • Potential immune-mediated diseases (pIMDs) are a subset of AEFIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
  • Number of subjects reporting pregnancies and outcomes of reported pregnancies
    • Time Frame: Throughout the study period (from Day 1 up to either 12 months following the third immunisation or 24 months following the first immunisation with Cervarix, whichever occurs first.)
    • The number of subjects reporting pregnancies and outcomes of reported pregnancies (elective abortion for medical reasons, spontaneous abortion or congenital anomaly) when Cervarix is administered to the subject, inadvertently within 60 days before pregnancy onset, or any time during pregnancy, is reported. Note: Subjects who report exposure to Cervarix during pregnancy or pregnancy onset up to 60 days following the last immunisation are followed-up till end of pregnancy, to observe the pregnancy outcome(s) and for any possible congenital anomalies diagnosed during the first 12 months of the child’s life. Thus, in such cases, an extended follow-up beyond 24 months may occur.
  • Number of subjects reporting pregnancies resulting in offspring with congenital anomalies
    • Time Frame: Throughout the study period (from Day 1 up to either 12 months following the third immunisation or 24 months following the first immunisation with Cervarix, whichever occurs first.)
    • The number of subjects reporting pregnancies resulting in offspring with congenital anomalies when Cervarix is administered inadvertently to the subject, within 60 days before pregnancy onset or any time during pregnancy, is reported. Note: Subjects who report exposure to Cervarix during pregnancy or pregnancy onset up to 60 days following the last immunisation are followed-up till end of pregnancy, to observe the pregnancy outcome(s) and for any possible congenital anomalies diagnosed during the first 12 months of the child’s life. Thus, in such cases, an extended follow-up beyond 24 months may occur.

Participating in This Clinical Trial

Inclusion Criteria

  • Any Chinese female subject aged between 9 and 45 years, at the time of first vaccination dose, who will receive voluntary vaccination. – Subjects for whom the investigator believes that they or their parent(s)/LAR(s) can and will comply with the requirements mentioned in the protocol (e.g., return for the subsequent dose of vaccination and follow-up visits) will be included in the study. – Written informed consent will be obtained from the subject. For subjects who are below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject according to EC requirement as well as local law. Exclusion Criteria:
  • • Child in care

    Gender Eligibility: Female

    Minimum Age: 9 Years

    Maximum Age: 45 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • GlaxoSmithKline
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • GSK Clinical Trials, Study Director, GlaxoSmithKline

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