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A Safety and Immunogenicity Study of IVACFLU-A/H5N1

NCT02612909 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 930

Last updated 2019-05-21

Study results available
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Summary

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

Conditions

  • Avian Influenza

Interventions

BIOLOGICAL

IVACFLU-A/H5N1 vaccine

Monovalent A/H5N1 influenza vaccine (MIV), whole virion inactivated, purified by sucrose gradient on ultracentrifuge. The vaccine was produced in eggs, inactivated with formaldehyde, and formulated with aluminum hydroxide 0.6 mg/0.5 mL with no preservative.

BIOLOGICAL

Placebo

Includes 4.500mg sodium chloride, 0.685 mg sodium phosphate dibasic dihydrate, and 0.186 mg sodium phosphate monobasic dihydrate.

Sponsors & Collaborators

Principal Investigators

  • Tran N Duong, MD, PhD · National Institute of Hygiene and Epidemiology, Vietnam

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2017-08-29
Completion
2017-08-30

Countries

  • Vietnam

Study Locations

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Entities

Drugs
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 NCT02612909 on ClinicalTrials.gov