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

NCT ID: NCT06280144

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 6080 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2024-10-30

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.

Conditions

Influenza Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

Influenza Vaccine, Live, Nasal, Freeze-dried

Group Type: EXPERIMENTAL

Influenza Vaccine, Live, Nasal, Freeze-dried

Intervention Type: BIOLOGICAL

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 group

Sterile water for inhalation

Group Type: PLACEBO_COMPARATOR

Sterile water for inhalation

Intervention Type: OTHER

Sterile water for inhalation

Interventions

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

Intervention Type: BIOLOGICAL

Sterile water for inhalation

Sterile water for inhalation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hu Bei province Center for Disease control and prevention

UNKNOWN

Sponsor Role: collaborator

The Inner Mongolia Autonomous Region Center for Disease Control and Prevention

UNKNOWN

Sponsor Role: collaborator

Changchun BCHT Biotechnology Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chifeng, Inner Mongolia, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xibao Huang

Role: CONTACT

hxb6407@163.com

027-87652133

Xiaoling Tian

Role: CONTACT

txlingok@126.com

13848710296

Facility Contacts

Xiaoling Tian

Role: primary

txlingok@126.com

13848710296

Other Identifiers

PF20230428

Identifier Type: -

Identifier Source: org_study_id