The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

March 9, 2022 updated by: Changchun BCHT Biotechnology Co.

A Random, Double-Blind, Multicenter, Positive Control and Placebo Control Phase Two Trail to Evaluate the Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2520

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Healthy people in placebo group will receive a dose of placebo
Biological: Live Attenuated Influenza Vaccine placebo
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
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)
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
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)
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun BCHT Biotechnology Co.

Collaborators

He Bei province Center for Disease control and prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bchtpharm

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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