Phase III, Multicenter Study to Evaluate the Safety, immune response, and effectiveness of Two Doses of aH5N1 vaccine when Administered to Adult and Elderly Subjects With and Without Immunosuppresive Diseases.
- Conditions
- Pandemic InfluenzaTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-003573-28-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
- 540
All subjects
1. Male and female individuals 18 years of age and older at the time of enrollment who are noninstitutionalized, mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry
2. Individuals with a projected life expectancy of 12 months or longer
3. Individuals who are able to comply with all study procedures and requirements
Subjects with immunosuppressive conditions only
4. Individuals with a confirmed diagnosis of only one of the following medical conditions
a. Transplant recipients: Adult subjects who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation, more than 3 months prior to enrollment
b. HIV-1 infected subjects:
i. Adults with Confirmed Diagnosis of HIV-1 infection
ii. CD4+ cell count >200 per mm³ within 3 months prior to the study enrollment
iii. HIV-1 viral load under 200 copies/mL within 90 days prior to the inclusion in the study
iv. No changes in the antiviral therapy (including highly active antiretroviral therapy (HAART) during the previous 4 weeks and/or change in the antiviral therapy anticipated through day 43 (3 weeks after the second dose of the vaccine)
v. No use of immunomodulatory therapy, including cyclosporine, products containing IgG, interleukins, interferons, or systemic glucocorticoids (including inhalatory) within 3 months before study inclusion
c. Patients with hematologic malignancies or patients who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies
5. Subjects with above mentioned immunosuppressive conditions with other underlying diseases must have stable medical control of these diseases for at least 3 months prior to enrollment in the judgment of the investigator
Healthy subjects only
6. Individuals who are in good health as determined by the outcome of medical history, physical assessment, and 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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270
All
1. Individuals who are not able to follow all the required study procedures for the whole period of the study
2. 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
3. Individuals who are hospitalized or residing in a nursing care facility
4. Individuals who are planning to change their home address due to relocation during the course of the trial and may become unavailable for follow-up
5. Individual with any fatal prognosis of an underlying medical condition (<12 months life expectancy)
6. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome
7. Individuals who have received other nonstudy vaccines within 7 days of either day 1 or day 22 vaccination
8. Individuals who have ever received an H5N1 vaccine
9. Individuals who are receiving another investigational product within 30 days prior to day 1 or before completion of the safety Follow-up Period in another study and who are unwilling to refuse participation in another clinical study at any time during conduct of this study
Note: Concomitant participation in an observational study (not involving drugs, vaccines, or medical devices) is acceptable
10. Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the following: influenza viral proteins, excipient(s) of the study or reference vaccine (see section 5.0), eggs (including ovalbumin), or chicken protein
11. Individuals with history of (or current) drug or alcohol abuse that, in the Investigator's opinion, would interfere with the safety of the subject or the evaluation of study objectives
12. Individuals who will undergo surgery planned during the study period that, in Investigator's opinion, would interfere with the study visit schedule
13. Individual who is a member of the research staff or has relatives who are members of the research staff (research staff are individuals with direct contact with study subjects or study site personnel who have access to any study document contraining subject information, including receptionists, persons scheduling appointments or making screening calls, regulatory specialists, or laboratory technicians). Hospital personnel, health care professionals, and their relatives who are not involved in this clinical study are allowed for inclusion
14. Female subjects of childbearing potential who are sexually active and have not used for at least 2 months prior to study entry one or more of the following acceptable contraceptive methods:
- Hormonal contraceptive (oral, injection, transdermal patch, implant, cervical ring)
- Barrier (condom with or without spermicide or diaphragm with spermicide) each and every time during intercourse
- Intrauterine device
- Monogamous relationship with vasectomized partner (partner must have been vasectomized for at least 6 months prior to the subject's study entry)
- Abstinence, if not sexually active, at least 2 months before the study entry and at least 2 months after the study entry (through day 60 of study participation)
15. Female subjects of childbearing potential who have a positive pregnancy test prior to study entry, who are nursing (breastfeeding), or who are sexually active and have not used or do not plan to use acceptable contraceptive measures through day 60 of study participation.
16.
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