Last updated: 02/20/2024 09:31:24
Shingrix for intramuscular injection Drug Use Investigation
GSK study ID
212853
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title:
Trial description: The purpose of this prospective, descriptive, multi-center, cohort study is to assess the safety of Shingrix vaccine when administered in Japanese adults ≥50 Years of Age (YOA) for the first time.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of Solicited adverse events
Timeframe: During the 7-day follow-up period after each vaccine dose (day of vaccination designated as Day 1) for each subject.
Occurrence of Unsolicited adverse events
Timeframe: During the 30-day follow-up period after each vaccine dose (day of vaccination designated as Day 1) for each subject.
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
7500
Primary completion date:
2025-31-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
October 2020 to August 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- Subjects vaccinated with Shingrix for the first time
- Obtaining informed consent from vaccinated person (and/or person’s representative)
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Obtaining informed consent from vaccinated person (and/or person’s representative)
Subjects vaccinated with Shingrix for the first time
Exclusion criteria:
None
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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