Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434733

Enrollment

4400

Registered

2007-02-13

Start date

2007-01-31

Completion date

Unknown

Last updated

2008-04-24

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

Conditions

Influenza

Keywords

Influenza H5N1, pandemic

Brief summary

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Interventions

BIOLOGICALPandemic influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy Subjects 18 years of age who signed the informed consent

Exclusion criteria

* Receipt of another investigational agent within 4 weeks * Receipt of influenza vaccination for current season 2006/2007. * any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis * fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1) * Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control * Surgery planned during the study period * Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine * Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination * History of (or current) drug or alcohol abuse * Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Design outcomes

Primary

Measure	Time frame
Adverse event rate	—

Secondary

Measure	Time frame
Seroconversion and seroprotection after two doses of H5N1 vaccine	—

Countries

Poland

Outcome results

None listed

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