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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
6,680
Each human dose: 0.2 mL
Each human dose is 0.2 mL
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
Time frame: at 14 days post-vaccination
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
Time frame: at 14 days post-vaccination
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 post-vaccination
Time frame: 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
Time frame: Throughout the entire study period
Safety
Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination
Time frame: 14 days post-vaccination
Safety
Incidence of unsolicited adverse events within 30 days post-vaccination
Time frame: 30 days post-vaccination
Safety
Incidence of serious adverse events (SAEs) in all participants from vaccination to end of study
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Time frame: During the study period
Safety
Viral shedding assessment at Day 3, Day 7, and Day 15 post-vaccination
Time frame: Day 15 post-vaccination