Head to head study of influenza H1N1 vaccines in adults

Completed

• Conditions: Influenza due to other identified influenza virus; Pandemic H1N1 influenza 2009; Infections and Infestations

• Registration Number: ISRCTN92328241
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified