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Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines

NCT00478816 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-12-01

No results posted yet for this study

Summary

Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects

Conditions

  • Prophylaxis of Avian Influenza Vaccine

Interventions

BIOLOGICAL

Fluad H5N1 Pandemic Influenza Vaccine

Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines Information Service +41 61 324 1111 · Novartis

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United Kingdom

Study Locations

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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 NCT00478816 on ClinicalTrials.gov