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

A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00382187

Enrollment

Registered

2006-09-28

Start date

2006-11-30

Completion date

2008-01-31

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine, H5N1 influenza antigen, MF59, Pandemic influenza disease

Brief summary

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

Interventions

BIOLOGICALMF59 adjuvanted H5N1 influenza vaccine

* 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.	day 1 to day 43

Secondary

Measure	Time frame
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.	Day 1 to Day 382

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026