The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

NCT05056519 | Unknown Phase 1

• 1 other identifier: F20210719
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Influenza Prevention

Keywords

Safety; Immunogenicity; Live Attenuated Influenza Vaccine

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events as assessed by SAS v9.4

  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

  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

  The nasal secretions of Subjects in 18-59 years age group will be taken and be tested

  within 16 days after vaccination

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Biological: Live Attenuated Influenza Vaccine

Placebo group

PLACEBO COMPARATOR

Healthy people in placebo group will receive a dose of placebo

Biological: Live Attenuated Influenza Vaccine placebo

Interventions

Live Attenuated Influenza Vaccine BIOLOGICAL

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

Experimental group

Live Attenuated Influenza Vaccine placebo BIOLOGICAL

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

Placebo group

Eligibility Criteria

• Age: 3 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• He Bei province Center for Disease control and prevention: collaborator

Study Sites (1)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

RECRUITING

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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 .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 24, 2021
• Study Start: September 20, 2021
• Primary Completion: December 30, 2021
• Study Completion: March 30, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

CN (1)