The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-03-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Influenza Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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 .

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Live Attenuated Influenza Vaccine

Intervention Type BIOLOGICAL

Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.

Placebo group

Healthy people in placebo group will receive a dose of placebo

Group Type PLACEBO_COMPARATOR

Live Attenuated Influenza Vaccine placebo

Intervention Type BIOLOGICAL

Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.

Interventions

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Live Attenuated Influenza Vaccine

Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.

Intervention Type BIOLOGICAL

Live Attenuated Influenza Vaccine placebo

Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes