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A phase 3 randomized, observer-blind, controlled study to evaluate the clinical efficacy of an mRNA- based seasonal influenza vaccine in older adults ≥65 years of age

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526682-14-00
Enrollment
12000
Registered
2026-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-25

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

Conditions

Influenza, Human

Brief summary

First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, Occurrence of any solicited administration site and systemic events during the 7 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 7), Occurrence of unsolicited AEs during the 28 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 28), Occurrence of SAEs and AESIs up to the end of the corresponding influenza season (with at least 180 days of follow-up), For additional primary end points, kindly refer to the protocol (Section 3)

Detailed description

First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI, caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI, caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, First occurrence, at least 14 days after dosing, of cases of SID caused by influenza A or B, First occurrence, at least 14 days after dosing, of cases of SID caused by influenza A or B

Interventions

Sponsors

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, Occurrence of any solicited administration site and systemic events during the 7 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 7), Occurrence of unsolicited AEs during the 28 days (including the day of study intervention administration) following study intervention administration (Day 1 to Day 28), Occurrence of SAEs and AESIs up to the end of the corresponding influenza season (with at least 180 days of follow-up), For additional primary end points, kindly refer to the protocol (Section 3)—

Secondary

MeasureTime frame
First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI, caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, First occurrence, at least 14 days after dosing, of laboratory-confirmed cases of protocol-defined ILI, caused by influenza A subtypes H1N1 or H3N2 or influenza B/Victoria, First occurrence, at least 14 days after dosing, of cases of SID caused by influenza A or B, First occurrence, at least 14 days after dosing, of cases of SID caused by influenza A or B—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 26, 2026