MedTrace Logo

Panblok H7 Vaccine Adjuvanted With AS03 or MF59

NCT03283319 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2020-05-06

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

3.75 ug Panblok H7

0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.

BIOLOGICAL

7.5 ug Panblok H7

Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.

BIOLOGICAL

15 ug Panblok H7

Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.

BIOLOGICAL

MF59

0.5 mL MF59 (39 mg squalene/mL ) adjuvant.

BIOLOGICAL

AS03

0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.

Sponsors & Collaborators

Principal Investigators

  • Mark Adams, MD · Central Kentucky Research

  • Matthew Davis, MD · Rochester Clinical Research

  • Carlos Fierro, MD · Johnson County Clin-Trials

  • Terry Poling, MD · Heartland Research Associates

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
2017-09-20
Primary Completion
2017-12-15
Completion
2018-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03283319 on ClinicalTrials.gov