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The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Primary Purpose

Influenza Prevention

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Live Attenuated Influenza Vaccine
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 Safety, Immunogenicity, 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 half of years.
  • 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 from 18-59 age group with abnormal laboratory index. (slight abnormality is except if judged with no clinical significance by doctors.)
  • 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 PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine

Healthy people in placebo group will receive a dose of placebo

Outcomes

Primary Outcome Measures

Number of participants with adverse events as assessed by SAS v9.4
The incidence rate of adverse events in all subjects
Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
The incidence rate of abnormal of Blood routine, blood biochemical and urine in The incidence rate of abnormality of blood routine, blood biochemical and urine routine in 18-59 years age group
Number of participants with virus Shedding as assessed by SAS v9.4
The nasal secretions of Subjects in 18-59 years age group will be taken and be tested

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
September 23, 2021
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
NCT05056519
Brief Title
The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
Official Title
A Random, Double -Blind, Placebo Control Phase Ⅰ 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
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
March 30, 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 Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).
Detailed Description
Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1. 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
Safety, Immunogenicity, Live Attenuated Influenza Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Totally 160 in 3-59 years old healthy people will be divided into two age group, which contain 80 people in 18-59 years old and 80 people in 3-17 years old. In each age group, subjects will be randomly divided into vaccine group and placebo group in a ratio of 3:1.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The design of this trail is based on random, two-blind, placebo control. The subjects and investigators will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine
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
Intervention Description
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
Number of participants with adverse events as assessed by SAS v9.4
Description
The incidence rate of adverse events in all subjects
Time Frame
Within 31 days after vaccination
Title
Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
Description
The incidence rate of abnormal of Blood routine, blood biochemical and urine in The incidence rate of abnormality of blood routine, blood biochemical and urine routine in 18-59 years age group
Time Frame
3 days after vaccination
Title
Number of participants with virus Shedding as assessed by SAS v9.4
Description
The nasal secretions of Subjects in 18-59 years age group will be taken and be tested
Time Frame
within 16 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 half of years. 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 from 18-59 age group with abnormal laboratory index. (slight abnormality is except if judged with no clinical significance by doctors.) 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuliang Zhao, chief physician
Phone
+86-13315290538
Email
yuliang_zh@163.com

12. IPD Sharing Statement

Learn more about this trial

The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

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