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Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above

NCT00620815 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2016-03-28

Study results available
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Summary

Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)

Conditions

Interventions

BIOLOGICAL

MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine

Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.

BIOLOGICAL

Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1

Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.

BIOLOGICAL

Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine

Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.

BIOLOGICAL

Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1

Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.

BIOLOGICAL

Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine

Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

BIOLOGICAL

MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine

Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-01-31
Completion
2008-12-31

Countries

  • Germany

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 NCT00620815 on ClinicalTrials.gov