Pandemic H1N1 influenza 2009 Infections and Infestations Influenza due to other identified influenza virus
Conditions
Interventions
Group 1: Two doses of Baxter H1N1 vaccine, given 21 days apart
Group 2: Two doses of GSK H1N1 vaccine, given 21 days apart
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol 2. Clinically healthy, male or female volunteers aged 18 years of age and older, including the over 65's, and those with stable high-risk medical conditions. (NOTE: 'Stable' is defined as having no medical consultations for an exacerbation or worsening of any chronic medical condition during the preceding 8 weeks, AND have been maintained on a stable drug regimen for at least 2 weeks prior to study entry as assessed by the medical history) 3. Are able to understand and comply with all study procedures and to complete study diaries, 4. Individuals who can be contacted and are available for all study visits 5. 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-menopausal (defined as at least two years since the last menstrual period)
Exclusion criteria
Exclusion criteria: 1. Subjects who are unable to lead an independent life either physically or mentally 2. Women should not be pregnant or lactating 3. Women who refuse to use a reliable contraceptive method Days 0 to 42 of the study 4. Confirmed H1N1 infection, as determined by laboratory tests 5. Have received oseltamivir or zanamivir for influenza-like illness since May 2009 6. Have a household member who had confirmed H1N1 infection, as determined by laboratory tests, and/or received oseltamivir or zanamivir for influenza-like illness since May 2009 7. Receipt of another investigational agent (vaccine or medicinal product) in the preceding 4 weeks 8. Unwilling to refuse participation in another study during Days 0 to 42 of the study 9. Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder 10. 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) 11. Subjects who had a temperature >38°C within 3 days of vaccination 12. Any acute illness at the time of vaccination. Note: minor infections without fever or systemic upset are not contraindications/exclusion criteria. 13. Subjects with known or suspected impairment/alteration of immune function, including: 13.1. receipt of oral 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 (Note: long-term, inhaled steroids for asthma management is acceptable) 13.2. receipt of immunostimulants or interferon 13.3. receipt of an immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months of the study 13.4. Anyone at high risk of developing immunocompromising condition 13.5. Received radiotherapy or chemotherapy during the 6 months preceding the study 14. Subjects for whom surgery is planned during Days 0 to 42 of the study 15. Regularly drink more than 40 units of alcohol weekly 16. Known or suspected drug abuse (recreational or prescribed) 17. Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results 18. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin, products containing mercury, or any component of the study vaccines 19. Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine 20. Actual or planned receipt of another vaccine, including seasonal influenza vaccine, during the period 3 weeks before to 3 weeks after vaccination on Days 0 and 21
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of seroconversions or significant increase in haemagglutination inhibition (and microneutralisation) antibody titres 2. Mean geometric increase in haemagglutination inhibition (and microneutralisation) antibody titres 3. The proportion of subjects achieving an haemagglutination inhibition antibody titre of >40 These outcome measures are all part of the CPMP criteria and will be assessed in blood samples collected 21 days after the first and second doses of vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The kinetics of the haemagglutination inhibition and microneutralisation antibody responses to vaccination 2. The persistence of haemagglutination inhibition and microneutralisation antibody responses 6 months after vaccination 3. The breadth of the antibody response to any antigenic variant that might emerge before the 2010-2011 influenza season | — |
Countries
United Kingdom
Outcome results
None listed