Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Karl Nicholson


Contact details

Infectious Diseases Unit
Leicester Royal Infirmary
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 09/93/01

Study information

Scientific title

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.


Study hypothesis

Baxter 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

To be submitted as of 26 August 2009

Study design

Multi-centre randomised comparative study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Pandemic H1N1 influenza 2009


Group 1: Two doses of Baxter H1N1 vaccine, given 21 days apart
Group 2: Two doses of GSK H1N1 vaccine, given 21 days apart

Intervention type



Not Applicable

Drug names

H1N1 vaccines (Baxter and GSK vaccines)

Primary outcome measure

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 outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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)

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Infectious Diseases Unit
United Kingdom

Sponsor information


University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Mrs Carolyn Maloney
Leicester General Hospital
R&D Office
Gwendolen Road
United Kingdom
+44 (0)116 258 4109

Sponsor type




Funder type


Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2010 results in

Publication citations

  1. Results

    Nicholson KG, Abrams KR, Batham S, Clark TW, Hoschler K, Lim WS, Medina M, Nguyen-Van-Tam JS, Read RC, Warren FC, Zambon M, A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart., Health Technol Assess, 2010, 14, 55, 193-334, doi: 10.3310/hta14550-04.

Additional files

Editorial Notes