Status unknownNCT05284851Updated Mar 17, 2022

The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

A Phase 2 interventional study of Live Attenuated Influenza Vaccine(non freeze-dried) and Live Attenuated Influenza Vaccine(freeze-dried) in Influenza Prevention, sponsored by Changchun BCHT Biotechnology Co.. Status unknown at 1 site in China. Open to participants aged 3 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Changchun BCHT Biotechnology Co. · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 2,520
Allocation: Randomized
Ages: 3 Years to 59 Years
Sex: All

Study 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).

Read the detailed description

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.

All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation. All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.

Conditions studied

Influenza Prevention

Keywords

Immunogenicity
Safety
Live Attenuated Influenza Vaccine

In context

Lead sponsor

Changchun BCHT Biotechnology Co. is the lead sponsor of 21 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years to 59 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 2,520 participants (estimated)

Study arms

Experimental
Experimental group 1
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)
Active comparator
Positive control group
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 comparator
Placebo group
Healthy people in placebo group will receive a dose of placebo
Biological: Live Attenuated Influenza Vaccine placebo

Interventions

BiologicalLive Attenuated Influenza Vaccine(non freeze-dried)
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
BiologicalLive Attenuated Influenza Vaccine(freeze-dried)
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
BiologicalLive Attenuated Influenza Vaccine placebo
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.

What researchers measure

Primary outcomes

The number of participants with positive sIgA as assessed by SAS v9.4
The Mucosal convention rate of sIgA in all subjects
Time frame: within 10 days after vaccination

Study locations

1 site

Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei 050021, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05284851
Lead sponsor: Changchun BCHT Biotechnology Co.
Collaborators: He Bei province Center for Disease control and prevention
Responsible party: Sponsor
First posted: Mar 17, 2022
Start date: Apr 1, 2022 (estimated)
Primary completion: May 1, 2022 (estimated)
Completion: Oct 1, 2022 (estimated)
Last update: Mar 17, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Live Attenuated Influenza Vaccine

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Changchun BCHT Biotechnology Co.

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