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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-59
SponsorChangchun BCHT Biotechnology Co.

About this trial

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

Eligibility criteria

Qualifiers

Healthy participants aged 18-59 years

Capable of providing informed consent in person

Willing and able to comply with all clinical trial requirements

Disqualifiers

Axillary temperature >37.0°C on enrollment day *

Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial

History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months

Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months

Trial design

Treatments tested in this trial

  • Placebo Group
  • Test Group

Treatment groups

6,680 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Changchun BCHT Biotechnology Co.

Lead sponsor

Hubei Provincial Center for Disease Control and Prevention

Collaborator

Center for Disease Control and Prevention, Fujian

Collaborator

Zhejiang Provincial Center for Disease Control and Prevention

Collaborator