A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of FLUAD-H5N1 (Surface Antigen Adjuvanted with MF59C.1)Influenza Vaccine in Non-elderly Adult and Elderly Subjects - ND
- Conditions
- Active immunoprofilaxis against potential pandemic influenza strain.MedDRA version: 9.1Level: LLTClassification code 10059429Term: Influenza immunisation
- Registration Number
- EUCTR2007-000165-38-IT
- Lead Sponsor
- OVARTIS VACCINES AND DIAGNOSTICS S.R.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female volunteers 18 years of age or older, mentally competent, willing and
able to give written informed consent prior to study entry
2. Previously participating in study V87P1, but did not receive the booster dose on
day 202
3. Able to comply with all the study requirements
4. In general good health as determined by:
a. Medical history
b. Physical examination
c. Clinical judgment of the investigator
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
1. Any serious disease such as:
a. Cancer (except for benign or localized skin cancer and non metastatic prostate
cancer not presently treated with chemotherapy)
b. Autoimmune disease (including rheumatoid arthritis)
c. Advanced atherosclerotic disease or complicated diabetes mellitus
d. Chronic obstructive pulmonary disease (COPD) that requires oxygen therapy
e. Acute or progressive hepatic disease
f. Acute or progressive renal disease
g. Congestive heart failure
2. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,
neomycin or polymyxin or any other component of the vaccine
3. History of neurological symptoms or signs, or anaphylactic shock following
administration of any vaccine
4. Known or suspected (or have a high risk of developing) impairment/ alteration of
immune function (excluding that normally associated with advanced age) resulting,
for example, from:
a. Receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or
cancer chemotherapy/radiotherapy) within the past 60 days and for the full length
of the study
b. Receipt of immunostimulants
c. Receipt of parenteral immunoglobulin preparation, blood products and/or plasma
derivates within the past 3 months
d. Suspected or known HIV infection or HIV-related disease
5. All females of childbearing potential who refuse to use an acceptable method of birth
control for 21 days after the booster vaccination and/or who refuse to perform a urine
pregnancy test prior to vaccination. Adequate contraception is defined as hormonal
(e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom
with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or
monogamous relationship with vasectomized partner who has been vasectomized for
6 months or more prior to the subject's study entry
6. Pregnant or breastfeeding
7. Receipt of another vaccine or any investigational agent within the past 4 weeks
8. Experience of any acute disease or infections requiring systemic antibiotic or antiviral
therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within
the past 7 days
9. Experience of fever (i.e., axillary temperature 38?C) within the past 3 days
10. Participation in another clinical study
11. Surgery planned during the study period
12. Any condition which, in the opinion of the investigator, might interfere with the
evaluation of the study objective
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method