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A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea

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ClinicalTrials.gov Identifier: NCT03671369
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.

Condition or disease Intervention/treatment
Neoplasms, Rectal Other: Safety data collection (following routine vaccination) by a continuous surveillance method.

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Study Type : Observational
Estimated Enrollment : 1710 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix When Administered According to the Approved Prescribing Information in Korea
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cervarix Group
The study group comprises of 9-25 year-old male and female subjects who will be administered 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects can be vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose is administered before 5 months after the first dose, the third dose vaccination is required. In the 3 doses schedule, if the vaccination schedule requires flexibility, the second dose can be administered between 1 and 2.5 months and the third dose can be administered between 5 and 12 months after the first dose.
Other: Safety data collection (following routine vaccination) by a continuous surveillance method.

This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.

All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) will be collected as part of safety data in this PMS.





Primary Outcome Measures :
  1. Number of subjects with adverse events (AEs) [ Time Frame: During the 30-day (Day 1 to Day 30) follow-up period after each vaccine dose ]

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    An AE 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 medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse.


  2. Number of subjects with serious adverse events (SAEs) [ Time Frame: Throughout the post-marketing surveillance (PMS) period up to 30 days (Day 1 to Day 30) after the last vaccine dose administered during subject's participation in the PMS ]
    A serious adverse event (SAE) 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 study subject.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Korean male and female subjects aged 9-25 years, who are eligible for the series of Cervarix vaccination, according to the locally approved PI.
Criteria

Inclusion Criteria:

  • Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.
  • Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.

Exclusion Criteria:

  • At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.
  • Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.
  • Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician.
  • 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): NCT03671369


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Korea, Republic of
GSK Investigational Site Recruiting
Gongju-si, Chungcheongnam-do, Korea, Republic of, 32555
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Heung Seo Kim         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 139-711
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Byung Wook Eun         
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: NCT03671369    
Other Study ID Numbers: 208710
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Human Papillomavirus Vaccine
Adverse events after vaccination
Safety
Serious adverse events after vaccination
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs