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

Influenza Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280144
• Other study ID #: PF20230428
• Status: Recruiting
• Phase: Phase 4
• Start date: September 22, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: December 2023
• Source: Changchun BCHT Biotechnology Co.
• Contact: Xibao Huang
• Phone: 027-87652133
• Email: hxb6407[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6080
• Est. completion date: October 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza Prevention
• Influenza, Human

Intervention

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

Other:
• Sterile water for inhalation
Sterile water for inhalation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Changchun BCHT Biotechnology Co.	Hu Bei province Center for Disease control and prevention, The Inner Mongolia Autonomous Region Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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	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	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	Secondary protective efficacy endpoint	Protective effect of 14 days on the incidence of influenza-like cases.	Seven months
Secondary	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
Secondary	Study on detoxification	Proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15).	15 days