The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

NCT05284851 | Unknown Phase 2

• 1 other identifier: Bchtpharm
• Study Type: interventional
• Target: 2,520
• Locations: 1 country
• Sites: 1

Brief Summary

Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase two trail is to evaluate the immunogenicity of LAVI (non freeze- dried). The secondary objective is to evaluate the safety of LAVI (non freeze- dried).

Conditions

Influenza Prevention

Keywords

Immunogenicity; Safety; Live Attenuated Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

• The number of participants with positive sIgA as assessed by SAS v9.4

  The Mucosal convention rate of sIgA in all subjects

  within 10 days after vaccination

Study Arms (3)

Experimental group 1

EXPERIMENTAL

Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine (non freeze- dried)

Biological: Live Attenuated Influenza Vaccine(non freeze-dried)

Positive control group

ACTIVE COMPARATOR

Healthy people in Positive control group will receive a dose of Live Attenuated Influenza Vaccine ( freeze- dried)

Biological: Live Attenuated Influenza Vaccine(freeze-dried)

Placebo group

PLACEBO COMPARATOR

Healthy people in placebo group will receive a dose of placebo

Biological: Live Attenuated Influenza Vaccine placebo

Interventions

Live Attenuated Influenza Vaccine(non freeze-dried) BIOLOGICAL

Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.

Experimental group 1

Live Attenuated Influenza Vaccine(freeze-dried) BIOLOGICAL

Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.

Positive control group

Live Attenuated Influenza Vaccine placebo BIOLOGICAL

Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.

Placebo group

Eligibility Criteria

• Age: 3 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy volunteers aged in 3-59 years old
• Had not received vaccination of Influenza vaccine in the past one year
• Had not infected with Influenza virus
• This trail has been agreed by volunteers or his/her legal guardian
• Volunteers or his/her legal guardian will fellow this trail protocol

You may not qualify if:

• People with fever before vaccination, temperature higher than 37.0 #
• Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant
• People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination
• According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials
• Acute infectious disease or acute attack of chronic disease before inoculation
• People get any vaccine within 14 days before the trial
• People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, people with immunosuppressive therapy in the past six months
• People with epilepsy or a history of mental illness

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• He Bei province Center for Disease control and prevention: collaborator

Study Sites (1)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The design of this trail is based on random, one-blind, placebo control. The subjects will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

CN (1)