A randomized, observer-blind, dose-ranging, single-centre, study to evaluate the safety, tolerability and immunogenicity of adjuvanted and non-adjuvanted influenza A/Hong Kong/1073/99 (H9N2) vaccines, containing four ascending concentrations of H9 haemagglutinin, in healthy, immunologically-naïve, adult subjects - H9N2 vaccine
- Conditions
- Vaccine study to assess the safety and immunogenicity of whole virus, alum-adjuvanted whole virus and virosomal A/HongKong/1073/99 (H9N2) vaccine in healthy adult volunteers
- Registration Number
- EUCTR2005-000101-54-GB
- Lead Sponsor
- niversity Hospitals Leicester, Leicester General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 560
a) Mentally competent adults, who have signed an informed consent form after having recieved a detailed explanation of the study protocol.
b) Male or female subjects older than 18 and younger than 60 years who are either healthy or have a stable medical condition.
c) Able to understand and comply with all study procedures and to complete study diaries.
d) Individuals who can be contacted throughout the study and are available for all study visits.
e) Females should either be using secure contraceptive precautions, be surgically sterilised or post-menopausal( defined as at least two years since the last menstrual period).
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
a) Any clinically significant concurrent illness or unstable medical condition including:
malignant tumours, autoimmune illnesses(including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
b) Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitvity to eggs, chicken protein. chicken feathers, influenza viral protein, neomycin or polymixin, or products containing mercury.
c) Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or ther drugs listed in section 8 of the British National Formulary(BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to supress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
d) Subjects who are at high risk of developing illnesses of the immune system.
e) Individuals who are taking immunostimulant therapy or interferon.
f) Individuals who have received blood products or immunoglobulins parentally during the proceeding three months.
g) Women should not be pregnant of lactating.
h) Women who refuse to use a reliable contraceptive method throughout the study.
i) Known or suspected drug abuse.
j) Individuals who have received another vaccine or experimental ( investigational) drug in the preceding 4 weeks.
k) Individuals who have previously received H9N2 vaccine.
l) Unable to lead an independent life either physically or mentally.
m) Regularly drink more than 40 units of alcohol weekly.
n) Individuals who have had acute respiratory pathology or infections requiring systematic antibiotic or antiviral therapy during the preceding 7 days ( chronic antibiotic therapy for prevention of urinary tract infections is acceptable).
o) Individuals who had a temperature > 38C in the preceeding 3 days.
p) Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
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