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Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

NCT02680002 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2020-08-31

Study results available
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Summary

The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.

Conditions

  • A/Vietnam/H5N1 Influenza Virus

Interventions

BIOLOGICAL

7.5 mcg H5N1 (stored as monobulk)

BIOLOGICAL

15 mcg H5N1 (stored as monobulk)

BIOLOGICAL

90 mcg H5N1 (stored as monobulk)

BIOLOGICAL

90 mcg H5N1 (stored in vials)

OTHER

MF59

OTHER

MF59 (stored as monobulk)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-05-13
Completion
2017-03-31

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 NCT02680002 on ClinicalTrials.gov