Status:
COMPLETED
Safety and Immunogenicity of Influenza H9 Vaccine in Humans
Lead Sponsor:
University Hospitals, Leicester
Collaborating Sponsors:
Crucell Holland BV
National Institute of Biological Standards and Control
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
H9N2 influenza circulates in animal and poultry and has caused delf limiting infections in children. Influenza H9N2 poses a pandemic threat to humans. This study evaluates the safety and immunogenici...
Detailed Description
A double-blind, single centre comparative study in which fourteen groups of 40 male and female adults \>18 years of age will be randomly allocated to receive 1.7, 5, 15 or 45 µg quantities of whole vi...
Eligibility Criteria
Inclusion
- Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
- Male or female subjects over 18 years who are either healthy or have a stable medical condition.
- Able to understand and comply with all study procedures and to complete study diaries
- Individuals who can be contacted throughout the study and are available for all study visits
- Females should either be using secure contraceptive precautions including a) the oral contraceptive pill, b) condom/barrier contraception c) partner has had a vasectomy, d) be surgically sterilised, or e) post- (defined as at least two years since the last menstrual period)
Exclusion
- 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.
- Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to eggs, chicken protein, chicken feathers, influenzal viral protein, neomycin or polymixin, or products containing mercury.
- Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other 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 suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
- Subjects who are at high risk of developing illnesses of the immune system.
- Individuals who are taking immunostimulant therapy or interferon
- Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
- Women should not be pregnant or lactating.
- Women who refuse to use a reliable contraceptive method throughout the study
- Known or suspected drug abuse.
- Individuals who have received another vaccine or experimental (investigational) drug in the preceding 4 weeks.
- Individuals who have previously received H9N2 vaccine
- Unable to lead an independent life either physically or mentally
- Regularly drink more than 40 units of alcohol weekly
- Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable).
- Individuals who had a temperature over 38 degrees C in the preceding 3 days.
- Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT00814229
Start Date
August 1 2007
End Date
September 1 2008
Last Update
July 21 2009
Active Locations (1)
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1
University Hospitals Leicester
Leicester, Leicestershire, United Kingdom, LE1 5WW