Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults

This is an interventional prevention trial for Influenza focused on measuring influenza, immunogenicity, vaccine Read More

Inclusion Criteria:

1. Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
2. Male or female subjects 18-50 years who are either healthy or have a stable medical condition.
3. Able to understand and comply with all study procedures and to complete study diaries
4. Individuals who can be contacted throughout the study and are available for all study visits

5. Females should either be using secure contraceptive precautions including:

   • the oral contraceptive pill
   • condom/barrier contraception
   • partner has had a vasectomy
   • be surgically sterilised, or
   • post-menopausal (defined as at least two years since the last menstrual period)

Exclusion Criteria:

1. 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.
2. Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury.
3. 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.
4. Subjects who are at high risk of developing illnesses of the immune system.
5. Individuals who are taking immunostimulant therapy or interferon
6. Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
7. Women should not be pregnant or lactating.
8. Women who refuse to use a reliable contraceptive method throughout the study
9. Known or suspected drug abuse.
10. Individuals who have received another vaccine or investigational medicinal product in the preceding 2 weeks.
11. Unable to lead an independent life either physically or mentally
12. Regularly drink more than 40 units of alcohol weekly
13. 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).
14. Individuals who had a temperature >38oC in the preceding 3 days.
15. Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
16. Individuals who have had confirmed pandemic influenza H1 infection