A randomised, partially observer-blind, multi-centre, head-to-head comparison of a two dose regimen of Baxter and GSK H1N1 pandemic vaccines, administered 21 days apart - Head to head study of influenza H1N1 vaccines in adults

• Conditions: Pandemic H1N1 influenza.

• Registration Number: EUCTR2009-015743-16-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
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).
Are able to understand and comply with all study procedures and to complete study diaries,
Individuals who can be contacted 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-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

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 >38oC 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:
• 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 (Note: long-term, inhaled steroids for asthma management is acceptable),
• receipt of immunostimulants or interferon,
• receipt of an immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months of the study;
• Anyone at high risk of developing immunocompromising condition;
• 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 a history of anaphylaxis or serious reactions to vaccines; known hypersensitivity (other than anaphylactic reaction) to influenza viral protein, to any component of the study vaccines, to products containing mercury and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate, sodium deoxycholate, and benzonase).
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 clinical trial of medicinal product
• Study Design: Not specified