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A phase 3 randomized, observer-blind, controlled study to evaluate the immunogenicity, reactogenicity and safety of an mRNA-based seasonal influenza vaccine, in adults 18-64 years of age

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526925-17-00
Enrollment
1500
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

•HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29, Solicited AEs • Occurrence of any solicited administration site and systemic events during the 7 days following study intervention administration. Unsolicited AEs • Occurrence of unsolicited AEs during the 28 days following study intervention administration. MAAEs, SAEs and AESIs • Occurrence of SAEs and AESIs up to 6 months following study intervention administration.

Detailed description

• HI titers at Day 29 • HI seroconversion from baseline to Day 29, • Fold increase in HI titers at Day 29 relative to baseline • HI seroprotection at baseline and Day 29 • NI titers at Day 29 • Fold increase in NI titers at Day 29 relative to baseline • NI seroconversion from baseline to Day 29 • Virus neutralization titers at Day 29 by MN assay • Fold increase in virus neutralization titers at Day 29 relative to baseline • Virus neutralization seroconversion from baseline to Day 29

Interventions

Sponsors

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
•HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29, Solicited AEs • Occurrence of any solicited administration site and systemic events during the 7 days following study intervention administration. Unsolicited AEs • Occurrence of unsolicited AEs during the 28 days following study intervention administration. MAAEs, SAEs and AESIs • Occurrence of SAEs and AESIs up to 6 months following study intervention administration.—

Secondary

MeasureTime frame
• HI titers at Day 29 • HI seroconversion from baseline to Day 29, • Fold increase in HI titers at Day 29 relative to baseline • HI seroprotection at baseline and Day 29 • NI titers at Day 29 • Fold increase in NI titers at Day 29 relative to baseline • NI seroconversion from baseline to Day 29 • Virus neutralization titers at Day 29 by MN assay • Fold increase in virus neutralization titers at Day 29 relative to baseline • Virus neutralization seroconversion from baseline to Day 29—

Outcome results

None listed

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