- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310472
Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility
The goal of this intervention study is to learn if giving children influenza vaccinations in early childhood education facilities (i.e., daycare) will increase vaccination coverage compared to giving vaccinations only at healthcare. The main question it aims to answer is:
• Does offering children nasal influenza vaccine in daycare result in higher proportion of children getting influenza vaccine.
Researchers will compare daycare setting and healthcare setting as the location of giving influenza vaccines to children to see if more children will get vaccinated if they have an opportunity to receive nasal influenza vaccine at daycare.
Participants in the intervention group will:
• Have the opportunity to receive influenza vaccine in the daycare or in the healthcare
Participants in the comparison group will:
• Have the opportunity to receive influenza vaccine in the healthcare only
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ville Peltola, MD, PhD
- Phone Number: +35823132415
- Email: ville.peltola@varha.fi
Study Locations
-
-
-
Turku, Finland, 20014
- Recruiting
- University of Turku
-
Contact:
- Ville Peltola, MD, PhD
- Phone Number: +35823132415
- Email: ville.peltola@varha.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Attending early childhood education (daycare) in the city of Turku
Exclusion Criteria:
- No exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants are offered a nasal influenza vaccine at daycare
|
The intervention is the possibility to get influenza vaccine in the daycare, in comparison to routine practice of getting influenza vaccine in a healthcare setting.
|
|
No Intervention: Comparison group
Participants are not offered a nasal influenza vaccine at daycare
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Influenza vaccination coverage
Time Frame: From enrollment to the end of seasonal influenza vaccinations about 3 to 10 weeks later.
|
Study child receiving any influenza vaccine
|
From enrollment to the end of seasonal influenza vaccinations about 3 to 10 weeks later.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T2025/11144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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