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Phase IV open-label clinical trial of the immunogenicity and safety of standard dose trivalent inactivated influenza vaccine (Vaxigrip) in a population of people with obesity

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522698-13-00
Enrollment
100
Registered
2025-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-23

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

Conditions

Influenza, Obesity, Type 2 diabetes

Brief summary

Hemaglutinnin Inhibition Assay GMTs at day 0 (pre-vaccination) and at 14 days post-vaccination with Vaxigrip., The proportion of participants achieving a protective hemagluttinin inhibition assay titre ≥40 at 14 days post-vaccination., The proportion of participants achieving a four-fold rise in hemagluttinin inhibition assay titre at 14 days post-vaccination.

Detailed description

Incidence of solicited local (injection site) and systemic AEs in the 7-days post-vaccination., Incidence of SAEs, unsolicited AEs and fatal AEs during the period of the study.

Interventions

DRUGVaxigrip injektionsvätska
DRUGsuspension
DRUGi förfylld spruta. Trivalent influensavaccin (spjälkat virus
DRUGinaktiverat).

Sponsors

Region Stockholm – SLSO
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Hemaglutinnin Inhibition Assay GMTs at day 0 (pre-vaccination) and at 14 days post-vaccination with Vaxigrip., The proportion of participants achieving a protective hemagluttinin inhibition assay titre ≥40 at 14 days post-vaccination., The proportion of participants achieving a four-fold rise in hemagluttinin inhibition assay titre at 14 days post-vaccination.

Secondary

MeasureTime frame
Incidence of solicited local (injection site) and systemic AEs in the 7-days post-vaccination., Incidence of SAEs, unsolicited AEs and fatal AEs during the period of the study.

Countries

Sweden

Outcome results

None listed

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