Last updated: 02/21/2024 11:50:37
Post-marketing surveillance study to monitor the safety of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster Subunit vaccine, Shingrix, when administered according to the approved prescribing information in Korea
GSK study ID
213965
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A prospective, open-label, single-arm, multi-centre, post-marketing surveillance (PMS) study to monitor the safety of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster Subunit Vaccine, Shingrix, when administered according to the approved Prescribing Information (PI) in Korea
Trial description: The purpose of this post-marketing surveillance study is to assess the safety of GSK Biologicals’ Herpes Zoster Subunit vaccine, Shingrix, when administered to adults, in real-world routine clinical practice settings according to approved local prescribing information.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants reporting adverse events (AEs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting adverse drug reactions (ADRs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting serious adverse events (SAEs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting serious adverse drug reactions (SADRs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting unexpected adverse events (UAEs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting unexpected adverse drug reactions (UADRs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting unexpected serious adverse events (USAEs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting unexpected serious adverse drug reactions (USADRs)
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting each solicited local AEs
Timeframe: Within 7 days (Day 1 to Day 7) after each dose
Percentage of participants reporting each solicited general AEs
Timeframe: Within 7 days (Day 1 to Day 7) after each dose
Percentage of participants reporting unsolicited AEs
Timeframe: Within 30 days (Day 1 to Day 30) after each dose
Percentage of participants reporting potential immune mediated diseases (pIMDs)
Timeframe: Within 42 days (Day 1 to Day 42) after each dose
Percentage of participants reporting pregnancy safety outcomes
Timeframe: Up to 6-8 weeks after estimated delivery date
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
720
Primary completion date:
2026-14-12
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)
May 2023 to March 2027
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the diary cards, return for follow-up visits).
- 2. Korean male or female participants aged 18 years of age and older who are eligible for Shingrix according to the locally approved indication.
- 1. Participants who have contraindication for receiving Shingrix indicated in the locally approved PI.
- 2. Participants who are not appropriate for vaccination with Shingrix according to the medical judgement of the investigator.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the diary cards, return for follow-up visits). 2. Korean male or female participants aged 18 years of age and older who are eligible for Shingrix according to the locally approved indication. 3. Written informed consent obtained from the participants.
Exclusion criteria:
- 1. Participants who have contraindication for receiving Shingrix indicated in the locally approved PI. 2. Participants who are not appropriate for vaccination with Shingrix according to the medical judgement of the investigator.
Trial location(s)
Location
GSK Investigational Site
Cheonan-si, South Korea, South Korea, 31019
Status
Recruiting
Location
GSK Investigational Site
Cheongju-si, South Korea, South Korea, 28120
Status
Recruiting
Location
GSK Investigational Site
Dongnae-gu, South Korea, South Korea, 47830
Status
Recruiting
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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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