Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hu Bei province Center for Disease control and prevention | UNKNOWN |
| The Inner Mongolia Autonomous Region Center for Disease Control and Prevention | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Influenza Vaccine, Live, Nasal, Freeze-dried |
|
| Placebo group | Placebo Comparator | Sterile water for inhalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine, Live, Nasal, Freeze-dried | 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 |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Subjects who meet the contraindications and precautions specified in the vaccine instructions:
Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort.
Have received any influenza vaccine during this natural year before entering the study
Those who have been diagnosed with influenza in this natural year before entering the study.
Any condition that the investigator judged to affect the trial.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xibao Huang | Contact | 027-87652133 | hxb6407@163.com | |
| Xiaoling Tian | Contact | 13848710296 | txlingok@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Chifeng | Inner Mongolia | 024000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D005612 | Freeze Drying |
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sterile water for inhalation | Other | Sterile water for inhalation |
|
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 |
| D015925 |
| Cryopreservation |
| D014021 | Tissue Preservation |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D011309 | Preservation, Biological |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |