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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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505255-51-00
Acronym
217917
Enrollment
2157
Registered
2023-11-06
Start date
2022-08-08
Completion date
Unknown
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Brief summary

Confirmed HZ cases during the total duration of the ZOSTER-101 study (Day 1 through Month 48).

Detailed description

Confirmed HZ cases since 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER- 101 study., Anti-gE antibody concentrations at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Frequency of gE-specific CD4+ T-cells secreting at least 2 activation markers (from among IFN-γ, IL-2, TNF-α, CD40L) at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Number and percentage of participants with SAEs which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER-101 study (Day 1 through Month 48)., Number and percentage of participants with pIMDs (serious and non-serious) which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER- 101 study (Day 1 through Month 48)., Number and percentage of participants with HZ-related complications of confirmed HZ during the total duration of the ZOSTER-101 study (Day 1 through Month 48).

Interventions

Sponsors

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Confirmed HZ cases during the total duration of the ZOSTER-101 study (Day 1 through Month 48).

Secondary

MeasureTime frame
Confirmed HZ cases since 1-month post Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER- 101 study., Anti-gE antibody concentrations at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Frequency of gE-specific CD4+ T-cells secreting at least 2 activation markers (from among IFN-γ, IL-2, TNF-α, CD40L) at Day 1*, Months 12, 24, 36 and 48 in ZOSTER-101 study., Number and percentage of participants with SAEs which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER-101 study (Day 1 through Month 48)., Number and percentage of participants with pIMDs (serious and non-serious) which are assessed as causally related to the study intervention by the investigator during the total duration of the ZOSTER- 101 study (Day 1 through Month 48)., Number and percentage of participants with HZ-related complications of confirmed HZ during the total duration of the ZOSTER-101 study (Day 1 through Month 48).

Countries

Czechia, Estonia, Finland, France, Germany, Italy, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026