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Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1

NCT02171819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-03-14

Study results available
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Summary

This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.

Conditions

  • Influenza A Subtype H5N1 Infection

Interventions

BIOLOGICAL

IVACFLU-A/H5N1, 7.5 mcg

Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.

BIOLOGICAL

IVACFLU-A/H5N1, 15 mcg

Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose

OTHER

Placebo Comparator

PBS, pH 7.2 in 0.5 mL single-dose vials.

Sponsors & Collaborators

Principal Investigators

  • Le Hoang San, MD · Pasteur Institute, Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Vietnam

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 NCT02171819 on ClinicalTrials.gov