NCT06280144

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,080 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-22
• Primary completion: 2024-06-30
• Completion: 2024-10-30
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: China