Status:
COMPLETED
The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
Influenza
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
This is a single-center, randomized, open-label trial designed to explore the interaction between mucosal microbiota colonization in the nasal cavity and gut and the immune response to an intranasal l...
Eligibility Criteria
Inclusion
- Individuals aged 6-17 years.
- Volunteers and their guardians are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
Exclusion
- Allergy to any component of the vaccine product, including eggs, excipients, or gentamicin sulfate.
- Individuals with acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, or fever.
- Pregnant or lactating women.
- Individuals with Leigh syndrome who are receiving treatment with aspirin or aspirin-containing medications.
- Individuals with immunodeficiency, immunosuppression, or those undergoing immunosuppressive therapy.
- Individuals with uncontrolled epilepsy, other progressive neurological disorders, or a history of Guillain-Barré syndrome.
- Individuals with rhinitis or asthma.
- Individuals with a personal or family history of seizures, chronic diseases, epilepsy, or allergic tendencies.
- Individuals who have received immunoglobulin injections within the last 3 months prior to vaccination.
- Individuals who have used other live attenuated vaccines within 1 month prior to vaccination.
- Individuals planning to use antiviral drugs for influenza within 48 hours before or 2 weeks after vaccination.
- Individuals planning to use any other intranasal medication within 2 days after vaccination.
Key Trial Info
Start Date :
September 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06609811
Start Date
September 21 2024
End Date
January 17 2025
Last Update
April 24 2025
Active Locations (1)
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1
Haizhou District Center for Disease Control and Prevention
Lianyungang, Jiangsu, China