Last updated: February 19, 2024
Sponsor: Changchun BCHT Biotechnology Co.
Overall Status: Active - Recruiting
Phase
4
Condition
N/ATreatment
Sterile water for inhalation
Influenza Vaccine, Live, Nasal, Freeze-dried
Clinical Study ID
NCT06280144
PF20230428
Ages 3-17 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Local residents aged between 3 and 17;
- People who signed the informed consent form and could actively cooperate with thestudy;
- Axillary body temperature of 37.0℃.
Exclusion
Exclusion Criteria:
- Subjects who meet the contraindications and precautions specified in the vaccineinstructions:
- Those known to be allergic to any ingredients of this product, including eggs,excipients, gentamycin sulfate;
- Patients with acute disease, severe chronic disease, the acute onset of chronicdisease and fever;
- Women in pregnancy;
- Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs;
- Immunodeficient, immunocompromised, or under immunosuppressive therapy;
- Patients with uncontrolled epilepsy and other progressive neurological diseases,patients with a history of Guillain-Barre syndrome; And g. patients with rhinitis (with a clear diagnosis and in the onset of rhinitis).
- Have received other clinical study drugs or were participating in other clinicaltrials within 1 month before entering the cohort.
- Have received any influenza vaccine during this natural year before entering the study
- Those who have been diagnosed with influenza in this natural year before entering thestudy.
- Any condition that the investigator judged to affect the trial.
Study Design
Total Participants: 6080
Treatment Group(s): 2
Primary Treatment: Sterile water for inhalation
Phase: 4
Study Start date:
September 22, 2023
Estimated Completion Date:
October 30, 2024
Study Description
Connect with a study center
Chi Feng, Inner Mongolia Autonomous Region 024000
ChinaActive - Recruiting

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