MedTrace Logo

Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults

NCT01640691 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-07-16

No results posted yet for this study

Summary

The objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.

Conditions

  • Pandemic Influenza

Interventions

BIOLOGICAL

Pandemic Influenza Vaccine (H5N1)

Inactivated whole-virion vaccine 1. Administration route: Intramuscular Injection 2. Dosing schedule: 2 injections - at Day 1 and Day 22 separately 3. Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004)

Sponsors & Collaborators

  • Adimmune Corporation

    lead INDUSTRY

Principal Investigators

  • Chih-Jen Chang, MD · National Cheng-Kung University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-07-10
Primary Completion
2013-01-02
Completion
2013-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT01640691 on ClinicalTrials.gov