Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine

Launched by CHANGCHUN BCHT BIOTECHNOLOGY CO. · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new nasal spray vaccine designed to protect against influenza (the flu) and possibly provide some protection against the novel coronavirus. The researchers want to find out how well the vaccine works 14 days after it's given and to ensure that it is safe for use, especially since this version of the vaccine is freeze-dried. The trial is currently looking for participants aged 3 to 17 who live locally and can agree to take part in the study.

If eligible, participants will receive the nasal spray vaccine and will be monitored to see how well it protects them against the flu and any potential side effects. However, some individuals cannot participate, including those with certain allergies, pregnant women, those with severe health conditions, and anyone who has recently received another flu vaccine or is currently in another clinical trial. This study will help determine the vaccine's effectiveness and safety, which is important for preventing the flu in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Local residents aged between 3 and 17;
• • 2. People who signed the informed consent form and could actively cooperate with the study；
• • 3. Axillary body temperature of 37.0℃.
• Exclusion Criteria:
• 1. Subjects who meet the contraindications and precautions specified in the vaccine instructions:
• • 1. Those known to be allergic to any ingredients of this product, including eggs, excipients, gentamycin sulfate;
• • 2. Patients with acute disease, severe chronic disease, the acute onset of chronic disease and fever;
• • 3. Women in pregnancy;
• • 4. Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs;
• • 5. Immunodeficient, immunocompromised, or under immunosuppressive therapy;
• • 6. 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).
• • 2. Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort.
• • 3. Have received any influenza vaccine during this natural year before entering the study
• • 4. Those who have been diagnosed with influenza in this natural year before entering the study.
• • 5. Any condition that the investigator judged to affect the trial.