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

Phase 4

Recruiting

• Conditions: Influenza Prevention
• Interventions: Biological: Influenza Vaccine, Live, Nasal, Freeze-dried; Other: Sterile water for inhalation

• Registration Number: NCT06280144
• Lead Sponsor: Changchun BCHT Biotechnology Co.

Brief Summary

To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.

To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.

Detailed Description

Main end point:

Primary influenza protective effect endpoint Protective effect of 14 days on laboratory-confirmed influenza cases. Protective effect of 14 days after receiving lyophilized nasal spray live attenuated influenza vaccine on laboratory-confirmed serotype influenza cases.

Secondary endpoints:

Secondary point of secondary endpoint Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 0 days later on laboratory-confirmed influenza cases.

Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on clinically diagnosed influenza cases.

Protective effect of live attenuated influenza-like vaccine 14 days against influenza-like cases.

safety Incidence of adverse events and serious adverse events within 0-30 days after immunization.

Study on detoxification Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).

Exploration endpoint:

14 days after the freeze-dried nose vaccine, the vaccine was protective for the detection of COVID-19 cases.

Study Timeline

• Study First Submitted: 2023-09-01
• Study Start: 2023-09-22
• Status Verified: 2023-12
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-06-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6080

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Influenza Vaccine, Live, Nasal, Freeze-dried	Influenza Vaccine, Live, Nasal, Freeze-dried
Placebo group	Sterile water for inhalation	Sterile water for inhalation

Primary Outcome Measures

Name	Time	Method
Primary influenza protective effect endpoint	7 months	Protective effect of 14-day live attenuated influenza vaccine on the incidence of laboratory-confirmed cases of serotype influenza.

Secondary Outcome Measures

Name	Time	Method
Safety	One month	Incidence of adverse events and serious adverse events within 0-30 days .AE at the inoculation site: runny nose / nasal congestion, sore throat Non-inoculation site (systemic) AEs (including vital signs): fever, cough, headache, fatigue, fatigue, nausea, vomiting, muscle pain, arthralgia, chills, anorexia, acute anaphylaxis (type I hypersensitivity).; Other AEs, SAEs, and pregnancy events incidence.
Study on detoxification	15 days	Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).
Secondary protective efficacy endpoint	Seven months	Protective effect of 14 days on the incidence of influenza-like cases.