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The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

NCT05056519 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-09-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

Live Attenuated Influenza Vaccine

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

BIOLOGICAL

Live Attenuated Influenza Vaccine placebo

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

Sponsors & Collaborators

  • He Bei province Center for Disease control and prevention

    collaborator UNKNOWN

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2021-12-30
Completion
2022-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056519 on ClinicalTrials.gov