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Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray

NCT04146623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-12-01

No results posted yet for this study

Summary

This study is being conducted to assess the safety, tolerability, and immunogenicity of the live-attenuated CodaVax-H1N1 influenza vaccine as compared to normal saline placebo both administered via intranasal spray to healthy adults.

Conditions

Interventions

BIOLOGICAL

CodaVax-H1N1 influenza vaccine

CodaVax-H1N1, a live attenuated vaccine (LAIV) strain based on the A/California/07/2009 (H1N1) influenza virus, administered once intranasally via a sprayer at a dose of 8 x10\^5 plaque forming units (PFU).

BIOLOGICAL

Normal Saline Placebo

Saline (0.9%) administered intranasally via sprayer

Sponsors & Collaborators

  • Codagenix, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2020-10-11
Completion
2020-11-11
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04146623 on ClinicalTrials.gov