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Optimizing the time of day of influenza vaccine administration in adults aged 60-85 years: A randomized controlled trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513558-30-00
Acronym
IIV-654
Enrollment
440
Registered
2024-08-15
Start date
2024-09-25
Completion date
2025-05-01
Last updated
2024-09-12

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

Conditions

Influenza

Brief summary

The increase in influenza vaccine strain-specific serum antibody titers from pre-vaccination (T0) to 28 days (+/- 3 days) post-vaccination (T1) as measured by HI assay.

Detailed description

The increase in influenza-specific T cell responses in PBMCs from pre-vaccination (T0) to 28 days (+/- 3 days) post-vaccination (T1) as measured by ELISpot., Chronotype, assessed via the micro-Munich Chronotype Questionnaire, The incidence of influenza virus infection, as determined by rapid influenza diagnostic self-tests, and self-reported influenza-like illness symptoms up to six months of follow-up.

Interventions

DRUGPNEUMOVAX 23 solution for injection in pre-filled syringe Pneumococcal Polysaccharide Vaccine
DRUGInfluvac Tetra suspension for injection in pre-filled syringe (influenza vaccine

Sponsors

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The increase in influenza vaccine strain-specific serum antibody titers from pre-vaccination (T0) to 28 days (+/- 3 days) post-vaccination (T1) as measured by HI assay.

Secondary

MeasureTime frame
The increase in influenza-specific T cell responses in PBMCs from pre-vaccination (T0) to 28 days (+/- 3 days) post-vaccination (T1) as measured by ELISpot., Chronotype, assessed via the micro-Munich Chronotype Questionnaire, The incidence of influenza virus infection, as determined by rapid influenza diagnostic self-tests, and self-reported influenza-like illness symptoms up to six months of follow-up.

Countries

Netherlands

Outcome results

None listed

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