MedTrace Logo

Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults

NCT04439695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-09-16

No results posted yet for this study

Summary

This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects.

Conditions

Interventions

BIOLOGICAL

Low dose

Low dose of KBP-V001

BIOLOGICAL

Intermediate dose

Intermediate dose of KBP-V001

BIOLOGICAL

High dose

High dose of KBP-V001

BIOLOGICAL

Placebo

Buffered Saline Solution

Sponsors & Collaborators

  • KBio Inc

    lead INDUSTRY

Principal Investigators

  • Hugh Haydon · Kentucky BioProcessing

  • Brandon Essink, MD · Meridian Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2021-02-25
Completion
2021-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT04439695 on ClinicalTrials.gov