Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311480

Enrollment

520

Registered

2006-04-06

Start date

2006-03-31

Completion date

Unknown

Last updated

2007-03-13

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

Conditions

Pandemic Influenza Disease

Keywords

influenza, pandemic influenza, influenza vaccine, adjuvanted influenza vaccine

Brief summary

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

Interventions

BIOLOGICALInfluenza vaccine surface antigen adjuvanted with MF59

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Male and female volunteers 18 years of age or older

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, 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	—

Secondary

Measure	Time frame
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026