A Phase II, Randomized, Partially observer-blind, Single-centre study to Evaluate Safety and Immunogenicity of MF59-adjuvanted or Non-adjuvanted H5N1 Booster Influenza Vaccines in Adults Primed with MF59-adjuvanted A/Vietnam/1194/04 (H5N1) vaccine - Prime-boost vaccination using H5N1 vaccines
- Conditions
- avian influenza
- Registration Number
- EUCTR2007-005233-11-GB
- Lead Sponsor
- niversity Hospitals Of Leicester NHS Trust, Gwendolen Road
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 780
Inclusion criteria
1. Subjects 18 to 59 years of age, or 60 years of age and older, mentally
competent, who have signed an informed consent form after having received a
detailed explanation of the study protocol;
2. Are in good health or have one or more stable (See footnote) medical conditions,
as determined by:
a. Medical history,
b. Physical examination,
c. Clinical judgment of the medical investigator;
3. Are able to understand and comply with all study procedures and to complete
study diaries, can be contacted, and will be available for study visits.
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. Receipt of another investigational agent within 3 months, or before completion of
the safety follow-up period in another study, whichever is longer, prior to
enrollment and unwilling to refuse participation in another clinical study through
the end of the study;
2. Subjects who experienced any acute disease or infection requiring systemic
antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract
prophylaxis is acceptable) during the 7 days preceding vaccination;
3. Subjects who experienced fever (defined as axillary temperature >=38C) within 3
days prior to Visit 1;
4. Subjects who are pregnant or breastfeeding;
5. Females of childbearing potential who refuse to use an acceptable method of
birth control for a period of 56 days before and after each 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), monogamous relationship with
vasectomised partner who has been vasectomised for 6 months or more prior to
the subject’s study entry, or abstain from heterosexual intercourse (e.g., through
sexual orientation or religious or other beliefs about premarital intercourse);
6. Subjects with any serious disease, including:
a. cancer,
b. acute or progressive hepatic disease,
c. acute or progressive renal disease,
d. chronic pulmonary disease requiring home oxygen therapy,
e. active neurological disorder,
f. autoimmune disease (including rheumatoid arthritis);
7. Subjects for whom surgery is planned during the study period;
8. Subjects with a bleeding diathesis;
9. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers,
influenza viral protein, neomycin or polymixin, or any other component of the
study vaccine;
10.Subjects with a history of any neurological symptoms and signs, or anaphylactic
shock following administration of any vaccine;
11. Subjects with known or suspected impairment/alteration of immune function, for
example, resulting from:
a. receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or
cancer chemotherapy) (long-term, inhaled steroids for asthma management is
acceptable),
b. receipt of immunostimulants or interferon,
c. receipt of parenteral immunoglobulin preparation, blood products, and/or
plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5
(Day 382), or planned during the full length of the study,
d. high risk from developing an immunocompromising disease;
12. Actual or planned receipt of another vaccine during the period 3 weeks before
to 3 weeks after vaccination on Days 1, 22, and 382;
13. Subjects with a history of (or current) drug or alcohol abuse (20g/day for
females; 30g/day for males) that in the investigator’s opinion would interfere
with safety of the subject or the evaluation of the study objectives;
14. Subjects who are unable to lead an independent life either physically or
mentally;
15. Have participated in a previous study of H5 avian influenza vaccine;
16. Have been previously vaccinated with a vaccine containing MF59 or similar
adjuvant;
17. Subjects with any co
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