Head to head study of influenza H1N1 vaccines in adults

ISRCTN ISRCTN92328241
DOI https://doi.org/10.1186/ISRCTN92328241
Protocol serial number HTA 09/93/01
Sponsor University Hospitals of Leicester NHS Trust (UK)
Funder NIHR Health Technology Assessment Programme - HTA (UK)
Submission date
26/08/2009
Registration date
28/08/2009
Last edited
16/05/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Karl Nicholson
Scientific

Infectious Diseases Unit
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Study information

Primary study designInterventional
Study designMulti-centre randomised comparative study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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.
Study objectivesBaxter cell-culture, non-adjuvanted, whole virus H1N1 vaccine, and GSK AS03-adjuvanted, split H1N1 vaccine both meet all three Committee of Human Medicinal Products (CHMP) criteria, either after one or two doses of vaccine
Ethics approval(s)To be submitted as of 26 August 2009
Health condition(s) or problem(s) studiedPandemic H1N1 influenza 2009
InterventionGroup 1: Two doses of Baxter H1N1 vaccine, given 21 days apart
Group 2: Two doses of GSK H1N1 vaccine, given 21 days apart
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)H1N1 vaccines (Baxter and GSK vaccines)
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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

Completion date07/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration360
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment07/09/2009
Date of final enrolment07/03/2010

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Infectious Diseases Unit
Leicester
LE1 5WW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2010 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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