Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility

NCT07310472 | Recruiting

• 1 other identifier: T2025/11144
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza Vaccination

Keywords

Influenza; Children; Vaccination coverage; Nasal influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Influenza vaccination coverage

  Study child receiving any influenza vaccine

  From enrollment to the end of seasonal influenza vaccinations about 3 to 10 weeks later.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants are offered a nasal influenza vaccine at daycare

Behavioral: Possibility to get live attenuated nasal influenza vaccine at daycare

Comparison group

NO INTERVENTION

Participants are not offered a nasal influenza vaccine at daycare

Interventions

Possibility to get live attenuated nasal influenza vaccine at daycare BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Attending early childhood education (daycare) in the city of Turku

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

University of Turku

Turku, 20014, Finland

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Ville Peltola, MD, PhD

CONTACT

+35823132415; ville.peltola@varha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Cluster-randomized study, daycare units being clusters for randomization. Data collection from the vaccination registry.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: October 27, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)