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| Name | Class |
|---|---|
| Hubei Provincial Center for Disease Control and Prevention | OTHER |
| Center for Disease Control and Prevention, Fujian | OTHER |
| Zhejiang Provincial Center for Disease Control and Prevention | OTHER_GOV |
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A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Spray Live Attenuated Influenza Vaccine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Group | Biological | Each human dose: 0.2 mL |
| |
| Test Group |
| Measure | Description | Time Frame |
|---|---|---|
| Protective Efficacy | To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years at 14 days post-vaccination | at 14 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Protective Efficacy | To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed vaccine-matched influenza in participants aged 18-59 years at 14 days post-vaccination | at 14 days post-vaccination |
| Protective Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| huan xiao li | Contact | 0431-87078176 | lixiaohuan@bchtpharm.com |
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| Biological |
Each human dose is 0.2 mL |
|
To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years post-vaccination |
| Throughout the entire study period |
| Protective Efficacy | To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed, vaccine-matched influenza in participants aged 18-59 years post-vaccination | Throughout the entire study period |
| Safety | Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination | 14 days post-vaccination |
| Safety | Incidence of unsolicited adverse events within 30 days post-vaccination | 30 days post-vaccination |
| Safety | Incidence of serious adverse events (SAEs) in all participants from vaccination to end of study | During the study period |
| Safety | Viral shedding assessment at Day 3, Day 7, and Day 15 post-vaccination | Day 15 post-vaccination |