Last updated: 02/14/2025 18:30:10

A Post Marketing Surveillance (PMS) study to assess the safety of Shingrix given according to prescribing information in China

GSK study ID
212290
See study documents
Clinicaltrials.gov ID
Not applicable
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-center post marketing surveillance (PMS) cohort study to monitor the safety of GlaxoSmithKline Biologicals’ (GSK) Shingrix vaccine in Chinese adults ≥50 years of age (YOA), when administered on a voluntary basis according to the local Prescribing Information (PI) as per local routine practice
Trial description: Shingrix (GSK’s Zoster vaccine) is the first shingles vaccine licensed for use in China for the prevention of shingles in adults ≥50 years of age (YOA). This study evaluated the safety of the vaccine up to a year following last vaccination.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence, intensity, and causal relationship to vaccination of MAEs, reported as a percentage of participants

Timeframe: During the 30-day period following each vaccination with GSK’s Zoster vaccine

Secondary outcomes:

Occurrence and causal relationship to vaccination of SAEs, reported as a percentage of participants

Timeframe: Within 30 days after each vaccination and from first vaccination until 12 months after the last vaccination with GSK’s Zoster vaccine

Occurrence and causal relationship to vaccination of pIMDs, reported as a percentage of participants

Timeframe: During the period starting at the first vaccination and ending 12 months following the last vaccination with GSK’s Zoster vaccine

Interventions:
Not applicable
Enrollment:
3300
Primary completion date:
2022-14-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Xinghuo Pang, O'Mareen Spence, Neeraj Parmar, Jing Wang, Tao Zhou, Xiang Guo, Audrey Colliou, Sheela Pradeep Sarang, Mitra Yousefi, Huifeng Yun. A prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the recombinant zoster vaccine in Chinese adults ≥50 years of age. Human vaccines & immunotherapeutics. 2024-Dec-31;20(1): 2439031. PMID: 39681337 DOI: 10.1080/21645515.2024.2439031
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
October 2020 to August 2023
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • Any Chinese male or female adult ≥50 YOA at the time of first vaccination dose, who has received voluntary vaccination and who plans to receive a 2-dose vaccination course on a voluntary basis.
  • Subjects for whom the investigator believes that they can and will comply with the requirements mentioned in the protocol (e.g., return for the follow-up visits/telephone contacts) will be included in the study.
  • The following 3 points that, in the opinion of the investigator evaluation, might interfere with the study.
  • Unable to comply with study requirements specified in the protocol;
Inclusion and exclusion criteria
Inclusion criteria:

    Any Chinese male or female adult ≥50 YOA at the time of first vaccination dose, who has received voluntary vaccination and who plans to receive a 2-dose vaccination course on a voluntary basis.

    • Subjects for whom the investigator believes that they can and will comply with the requirements mentioned in the protocol (e.g., return for the follow-up visits/telephone contacts) will be included in the study.
    • Written informed consent will be obtained from the subject/subject’s LAR.
Exclusion criteria:

    The following 3 points that, in the opinion of the investigator evaluation, might interfere with the study.

    • Unable to comply with study requirements specified in the protocol;
    • Participating in another study within 3 months before entering EPI-ZOSTER-034 study cohort;
    • The Investigator will have evaluated whether recipients meet vaccination requirements according to the PI and considered any contraindication.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Beijing, China, 100013
Status
Study Complete
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Location
GSK Investigational Site
Beijing, China, 100027
Status
Study Complete
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Location
GSK Investigational Site
Shanghai, China
Status
Study Complete
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Location
GSK Investigational Site
Shanghai, China, 200136
Status
Study Complete
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Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2022-14-10
Actual study completion date
2023-10-08

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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