212853 - Shingrix for intramuscular injection Drug Use Investigation

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46663
• EU PAS number:
  EUPAS46662
• Study ID:
  46663
• Official title and acronym:
  212853 - Shingrix for intramuscular injection Drug Use Investigation
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The purpose of this prospective, descriptive, multi-center, drug utilization study is to assess the safety of Shingrix vaccine when administered in Japanese adults for the first time.
• Study status:
  Ongoing

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 14/09/2020

Actual: 14/09/2020

Study start date

Planned: 31/10/2020

Actual: 09/10/2020

Date of final study report

Planned: 15/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-212853-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only