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The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Primary Purpose

Influenza Prevention

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Live Attenuated Influenza Vaccine(non freeze-dried)
Live Attenuated Influenza Vaccine(freeze-dried)
Live Attenuated Influenza Vaccine placebo
Sponsored by
Changchun BCHT Biotechnology Co.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Prevention focused on measuring Immunogenicity, Safety, Live Attenuated Influenza Vaccine

Eligibility Criteria

3 Years - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hebei Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Experimental group 1

Positive control group

Placebo group

Arm Description

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

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

Healthy people in placebo group will receive a dose of placebo

Outcomes

Primary Outcome Measures

The number of participants with positive sIgA as assessed by SAS v9.4
The Mucosal convention rate of sIgA in all subjects

Secondary Outcome Measures

Full Information

First Posted
March 9, 2022
Last Updated
March 9, 2022
Sponsor
Changchun BCHT Biotechnology Co.
Collaborators
He Bei province Center for Disease control and prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05284851
Brief Title
The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun BCHT Biotechnology Co.
Collaborators
He Bei province Center for Disease control and prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Prevention
Keywords
Immunogenicity, Safety, Live Attenuated Influenza Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model 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.
Masking
Participant
Masking Description
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 .
Allocation
Randomized
Enrollment
2520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine (non freeze- dried)
Arm Title
Positive control group
Arm Type
Active Comparator
Arm Description
Healthy people in Positive control group will receive a dose of Live Attenuated Influenza Vaccine ( freeze- dried)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Healthy people in placebo group will receive a dose of placebo
Intervention Type
Biological
Intervention Name(s)
Live Attenuated Influenza Vaccine(non freeze-dried)
Intervention Description
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
Intervention Type
Biological
Intervention Name(s)
Live Attenuated Influenza Vaccine(freeze-dried)
Intervention Description
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
Intervention Type
Biological
Intervention Name(s)
Live Attenuated Influenza Vaccine placebo
Intervention Description
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
Primary Outcome Measure Information:
Title
The number of participants with positive sIgA as assessed by SAS v9.4
Description
The Mucosal convention rate of sIgA in all subjects
Time Frame
within 10 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hebei Provincial Center for Disease Control and Prevention
City
Shijiazhuang Shi
State/Province
Hebei
ZIP/Postal Code
050021
Country
China

12. IPD Sharing Statement

Learn more about this trial

The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

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