A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuvanted with MF59C.1) Influenza Vaccines Containing 3.75 mcg or 7.5 mcg of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects - Dose reductio

• Conditions: Avian influenza

• Registration Number: EUCTR2009-012385-31-PL
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-09
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

1.Males and females 18 yrs of age and above on the day of enrollment.
2.Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator
3.Documented consent obtained after the nature of the study has been explained according to local regulatory requirements
4.Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study or who do not consent to the retention of the subject’s serum samples after study completion.
2.Individuals who have had influenza vaccine or documented suspected influenza disease within the past 6 months.
3.Individuals Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 6 days;
4.Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
5.Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
6.History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), chicken protein.
7.History of any serious disease, such as:
a.cancer
b.history of serious chronic diseases (cardiac, renal, hepatic, metabolic (including diabetes mellitus), rheumatologic (including autoimmune disease such as rheumatoid arthritis), neurologic (including history of atypical febrile seizure or history of Guillain-Barré disease), and hematologic (including bleeding diathesis))
c.history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome)
8.Known or suspected impairment/alteration of immune function, including:
a.Chronic use of oral steroids or any use of parenteral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
b.receipt of immunostimulants within 60 days prior to Visit 1
c.receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study
d.HIV infection or HIV-related disease
e.Heritable immunodeficiency
f.Abnormalities of splenic or thymic function
9.Pregnant or breast-feeding female
10.Any positive or indeterminate pregnancy test
11.If female, of childbearing potential, and has not used any of the acceptable contraceptive methods” for at least 2 months prior to study entry
a.Of childbearing potential is defined as status post onset of menarche and not surgically sterile
b.Acceptable birth control methods are defined as one or more of the following:
i.Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
ii.Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
iii.Intrauterine device (IUD)
iv.Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject’s study entry
12.If female of childbearing potential, refusal to use an acceptable contraceptive method” during the study including day 43.
13.If female of childbearing potential, refusal to submit for pregnancy testing prior to study vaccination
14.Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1. Laboratory-confirmed” includes:
a.Positive serology result
b.Positive viral culture
c.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified