Optimizing the time of day of influenza vaccine administration in adults aged 60-85 years: A randomized controlled trial
- Conditions
- InfluenzaTherapeutic area: Diseases [C] - Virus Diseases [C02]Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2024-513558-30-00
- Lead Sponsor
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
Aged 60-85 years at the time of inclusion., Willing and able to come to the vaccination location at a randomly assigned timeslot., Available for the follow-up period of 6 months., Have provided written informed consent.
Known or suspected allergy to any of the vaccine components or having experienced a previous severe adverse reaction to any vaccine., Known to have an increased susceptibility to bleeding (bleeding diathesis), and are therefore not suitable for intramuscular vaccination., Present evidence of serious diseases demanding either regular use of oral immunosuppressive medical treatment, like corticosteroids, three months prior to study enrolment, or demanding acute use of high dose oral immunosuppressives two weeks prior study to study enrolment., Receipt of an organ- or bone marrow transplant, Receipt of chemotherapy in the previous year., Receipt of blood products or immunoglobulins, within 3 months before study entry., Known or suspected immunodeficiency, auto-immune disease, any type of cancer., Known to be positive for human immunodeficiency virus, and/or hepatitis C virus and/or hepatitis B virus., Receipt of any vaccine(s), including the COVID-19 vaccine, less than two weeks prior to or within one month after baseline., Receipt of influenza 2024/2025-season vaccine prior to or within one month after baseline.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method