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Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

NCT01044095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-07-23

No results posted yet for this study

Summary

This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.

Conditions

Interventions

BIOLOGICAL

FluMist® live, attenuated, intranasal seasonal influenza vaccine

FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)

BIOLOGICAL

Fluzone® inactivated influenza virus vaccine

Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Sponsors & Collaborators

  • Armed Forces Research Institute of Medical Sciences, Thailand

    lead OTHER_GOV

Principal Investigators

  • Delia B Bethell, BM BCh · Armed Forces Research Institute of Medical Sciences, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-07-31
Completion
2012-06-30

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT01044095 on ClinicalTrials.gov