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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

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ClinicalTrials.gov Identifier: NCT03438006
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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.


Condition or disease Intervention/treatment
Cervical Intraepithelial Neoplasia Other: Safety data collection (following routine vaccination)

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Study Type : Observational
Actual Enrollment : 3017 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 4, 2020
Estimated Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy female Chinese subjects aged between 9 and 45 years, vaccinated on a voluntary basis as per standard practice.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438006


Locations
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China
GSK Investigational Site
Shanghai, China, 200030
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03438006     History of Changes
Other Study ID Numbers: 207350
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Safety
Human Papillomavirus Vaccine
Adverse Event Following Immunization
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs