The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

September 23, 2021 updated by: Changchun BCHT Biotechnology Co.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 1

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
        • Recruiting
        • Hebei Provincial Center for Disease Control and Prevention
        • Contact:

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 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine
Biological: Live Attenuated Influenza Vaccine
Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as assessed by SAS v9.4
Time Frame: Within 31 days after vaccination
The incidence rate of adverse events in all subjects
Within 31 days after vaccination
Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
Time Frame: 3 days after vaccination
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
3 days after vaccination
Number of participants with virus Shedding as assessed by SAS v9.4
Time Frame: within 16 days after vaccination
The nasal secretions of Subjects in 18-59 years age group will be taken and be tested
within 16 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)

September 20, 2021

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

March 30, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F20210719

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.

Clinical Trials on Influenza Prevention

Clinical Trials on Live Attenuated Influenza Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe