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Clinical Trials/JPRN-jRCT2071220038
JPRN-jRCT2071220038
Active, not recruiting
Phase 4

A phase 3b, open-label, multi-country, multi-centre, long-term follow-up study of ZOSTER-049 (follow-up of ZOSTER-006/022 studies) to assess the prophylactic efficacy, safety and persistence of immune response of a Herpes Zoster subunit vaccine and assessment of persistence of immune response and safety of 1 or 2 additional doses administered in ZOSTER-049 in 2 subgroups of older adults

Ogawa Masayuki0 sites129 target enrollmentStarted: August 5, 2022Last updated:
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ConditionsHerpes zoster (Shingles) disease.

Overview

Phase
Phase 4
Status
Active, not recruiting
Sponsor
Ogawa Masayuki
Enrollment
129
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 50age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • •Participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol.
  • •\-Written or witnessed/thumb printed informed consent obtained from the participant of the participant prior to performance of any study\-specific procedure.
  • •\-Medically stable participants as established by medical history and clinical examination before entering into the study.
  • •\-Participants who completed ZOSTER\-049 study (following at least 1 dose of HZ/su in ZOSTER\-006/022 studies).

Exclusion Criteria

  • •Medical conditions
  • •\-Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • •Prior/Concomitant therapy
  • •\-Use of any investigational or non\-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period.
  • •\-Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non\-registered vaccine other than HZ/su administered in studies ZOSTER\-006/022 or ZOSTER\-049\).
  • •Prior/Concurrent clinical study experience
  • •\-Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non\-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.

Investigators

Sponsor
Ogawa Masayuki

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