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

Multi-center, Randomized, Double-blind, Placebo-controlled Trial of a Live Attenuated Influenza Vaccine in People Aged 3-17

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza Prevention
• Intervention / Treatment: Biological: Influenza Vaccine, Live, Nasal, Freeze-dried; Other: Sterile water for inhalation

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 Type: Interventional
• Enrollment (Estimated): 6080
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xibao Huang; Phone Number: 027-87652133; Email: hxb6407@163.com
• Study Contact Backup: Name: Xiaoling Tian; Phone Number: 13848710296; Email: txlingok@126.com

Study Locations

• China
  • Inner Mongolia Autonomous Region
    • Chi Feng, Inner Mongolia Autonomous Region, China, 024000
      • Recruiting
      • Contact: Xiaoling Tian; Phone Number: 13848710296; Email: txlingok@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Influenza Vaccine, Live, Nasal, Freeze-dried	Biological: Influenza Vaccine, Live, Nasal, Freeze-dried; The titer of live attenuated influenza virus containing A (H1N1) and A (H3N2) should not be less than 6.9 lg EID50, and the titer of live attenuated influenza B virus should not be less than 6.4 lg EID50
Placebo Comparator: Placebo group; Sterile water for inhalation	Other: Sterile water for inhalation; Sterile water for inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary influenza protective effect endpoint	Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days on the incidence of laboratory-confirmed influenza cases	7 months
Primary influenza protective effect endpoint	Protective effect of 14-day live attenuated influenza vaccine on the incidence of laboratory-confirmed cases of serotype influenza.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary protective efficacy endpoint	Protective effect of freeze-dried nasal spray live attenuated influenza vaccine after 0 days on the incidence of laboratory-confirmed influenza cases.	Seven months
Secondary protective efficacy endpoint	Protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on the incidence of clinically diagnosed influenza cases.	Seven months
Secondary protective efficacy endpoint	Protective effect of 14 days on the incidence of influenza-like cases.	Seven months
Safety	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.	One month
Study on detoxification	Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).	15 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protective effect of COVID-19 cases.	14 days after inoculation of freeze-dried nasal influenza vaccine, the vaccine protected the incidence of COVID-19 cases.	Seven months

Collaborators and Investigators

• Sponsor: Changchun BCHT Biotechnology Co.
• Collaborators: Hu Bei province Center for Disease control and prevention; The Inner Mongolia Autonomous Region Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Protection effect
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PF20230428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No