Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

Novartis Vaccines40 enrolled

Overview

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Influenza

Interventions

MF59 adjuvanted H5N1 influenza vaccineBIOLOGICAL

* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 * non-adjuvanted influenza vaccine containing 15 ug of H5N1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female volunteers 18-60 years of age Exclusion Criteria: * Any auto-immune disease or other serious acute, chronic or progressive disease * Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine * History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy

Locations (1)

Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3

Siena, Siena, Italy

Outcomes

Primary Outcomes

CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.

Time frame: day 1 to day 43

Secondary Outcomes

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.

Time frame: Day 1 to Day 382

Data from ClinicalTrials.gov

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