Observational study to assess frailty of subjects during ZOSTER-006 and ZOSTER-022 and HZ efficacy, immunogenicity and safety of HZ/su by frailty status (ZOSTER-064)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38630
• EU PAS number:
  EUPAS38374
• Study ID:
  38630
• Official title and acronym:
  Observational study to assess frailty of subjects during ZOSTER-006 and ZOSTER-022 and HZ efficacy, immunogenicity and safety of HZ/su by frailty status (ZOSTER-064)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Brazil

  Canada

  Czechia

  Estonia

  Finland

  France

  Germany

  Hong Kong

  Italy

  Japan

  Korea, Republic of

  Mexico

  Spain

  Sweden

  Taiwan

  United Kingdom

  United States
• Study description:
  As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Multiple centres: 171 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 02/02/2018

Study start date

Actual: 05/06/2018

Date of final study report

Actual: 31/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-204878-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)