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Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943358
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : August 8, 2012
Public Health England
Novartis Vaccines
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief Summary:
The purpose of this study is to evaluate the antibody response to one and two doses of influenza A/H1N1v vaccine in healthy adults.

Condition or disease Intervention/treatment Phase
Influenza Biological: MF59 H1N1 vaccine Biological: Plain H1N1 vaccine Phase 1

Detailed Description:
An observer-blind, single-centre study in which 7 groups of 25-30 male and female adults ≥18-50 years of age will be randomly allocated to receive two doses of cell culture non-adjuvanted or MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 3.75, 7.5 or 15µg haemagglutinin by intramuscular injection. A second dose of the same vaccine containing the same quantity of antigen as in the first dose will be administered 21 days later. Three additional groups will receive two doses of MF59-adjuvanted influenza A/California/4/2009 (H1N1) surface antigen vaccine containing 7.5 µg haemagglutinin by intramuscular injection on day 0 or separated by 7 or 14 days. Subjects will be observed for local and systemic reactions for 30 minutes after each immunisation and will be monitored for any reactions and other adverse events for 7 days after each immunisation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Cell-culture Non-adjuvanted and MF59-adjuvanted Influenza H1N1 Vaccines in Healthy Adults
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Vaccine
adjuvanted influenza vaccine
Biological: MF59 H1N1 vaccine
3.75-7.5ug dose

Active Comparator: Vaccine 2
non-adjuvanted vaccine
Biological: Plain H1N1 vaccine

Primary Outcome Measures :
  1. GMT antibody rises [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. frequency of adverse reactions [ Time Frame: 42 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
  2. Male or female subjects 18-50 years who are either healthy or have a stable medical condition.
  3. Able to understand and comply with all study procedures and to complete study diaries
  4. Individuals who can be contacted throughout the study and are available for all study visits
  5. Females should either be using secure contraceptive precautions including:

    • the oral contraceptive pill
    • condom/barrier contraception
    • partner has had a vasectomy
    • be surgically sterilised, or
    • post-menopausal (defined as at least two years since the last menstrual period)

Exclusion Criteria:

  1. Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
  2. Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury.
  3. Persons with known immunosuppressive disease or who use systemic 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.
  4. Subjects who are at high risk of developing illnesses of the immune system.
  5. Individuals who are taking immunostimulant therapy or interferon
  6. Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
  7. Women should not be pregnant or lactating.
  8. Women who refuse to use a reliable contraceptive method throughout the study
  9. Known or suspected drug abuse.
  10. Individuals who have received another vaccine or investigational medicinal product in the preceding 2 weeks.
  11. Unable to lead an independent life either physically or mentally
  12. Regularly drink more than 40 units of alcohol weekly
  13. 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).
  14. Individuals who had a temperature >38oC in the preceding 3 days.
  15. Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
  16. Individuals who have had confirmed pandemic influenza H1 infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00943358

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United Kingdom
University Hospitals Leicester
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
Public Health England
Novartis Vaccines
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Principal Investigator: Iain Stephenson, FRCP University Hospitals, Leicester

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospitals, Leicester Identifier: NCT00943358    
Other Study ID Numbers: UHL10763
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Keywords provided by University Hospitals, Leicester:
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs