Clinical Trial: Phase III Study evaluating immunogenicity and safety of GSK Fluarix Influenza Vaccine

This study is no longer recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

- For each vaccine strain, seroconversion rate with 95% CI at day 21 defined as the proportion of vaccinees with at least a four-fold rise in HI titer.

  • For each vaccine strain, seroprotection rate with 95% CI at day 21 defined as the proportion of vaccinees with a serum HI titer ? 1:40. Immunogenicity:
  • For each vaccine strain, geometric mean titer (GMT) of serum HI antibodies with 95% CI pre- and post-vaccination.
  • For each vaccine strain, conversion factor at day 21 defined as the fold increase in serum HI GMT on day 21 compared to day 0.
  • For each vaccine strain, proportion of vaccinees with a four fold increase in HI titer if baseline titer is less than 1:40 Safety
  • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after vaccination.
  • Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21 day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination.
  • Occurrence of serious adverse events during the entire study.

Condition Treatment or Intervention Phase
Influenza
 Vaccine: Fluarix
Phase III

MedlinePlus related topics:  Influenza

Study Type: Interventional
Study Design: Prevention, Randomized, Placebo Control

Official Title: A randomized, double-blinded, placebo controlled Phase III Study to evaluate the immunogenicity and the safety of GSK Bio influenza vaccine (Fluarix) administered intramuscularly in healthy adults

Further Study Details: 

Expected Total Enrollment:  1050

Study start: December 2004;  Study completion: December 2004

A randomized, double-blinded, placebo controlled Phase III Study to evaluate the immunogenicity and the safety of GSK Bio influenza vaccine (Fluarix) administered intramuscularly in healthy adults. Immunization against influenza in healthy male and female subjects aged 18 to 64 years. Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. Following vaccination, seroprotective antibody titers are achieved in a high proportion of vaccinated subjects. GlaxoSmithKline Biologicals (GSK Bio) has been marketing an inactivated influenza split vaccine (Fluarix) since 1992. More than 126 million doses have been distributed and the vaccine is registered in 78 countries. It has been well tolerated and has proven to be highly immunogenic when injected by the intramuscular route.

Eligibility

Ages Eligible for Study:  18 Years   -   64 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:

  • A male or female age between 18 - 64 years at the time of the vaccination
  • Subjects who the investigator believes can and will comply with the requirement of the protocol (e.g. return for followup visit and completion of the diary cards)
  • Written informed consent obtained from the subject
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study
  • Female subject must be of non-childbearing potential i.e. either surgically sterilized or one year post-menopausal. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g. intrauterine contraceptive devise, oral contraceptiveor other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two monts after completion of vaccination.

EXCLUSION CRITERIA:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period
  • Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
  • Chronic administration (defines as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, equal or more than 0.5 mg/kg/day.)
  • Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study
  • History of hypersensitivity to a previous dose of influenza vaccine
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium deoxycholate
  • Previous vaccination against influenza (2004-2005 influenza vaccine) within the 9 months prior to enrollment
  • Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness i.e. oral temperature less than 37.5 C (99.5 F)/Axillary temperature less than 37.5 C(99.5 F)
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
  • Major congenital defects or serious chronic illness
  • History of any neurological disorders, including history of Guillain Barre syndrome
  • History of seizures, with the exception of a single febrile seizure during childhood
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of enrollment in this study
  • Has an underlying medical condition for which influenza vaccination is recommended: chronic heart or lung conditions, including asthma; metabolic diseases; kidney disease; blood disorder (such as sickle cell anemia); weakened immune system, including HIV/AIDS
  • 18 years of age and on chronic aspirin therapy
  • Residents of nursing homes and long term care facilities
  • Health care workers involved in direct patient care
  • Out-of-home caregivers and household contacts of children less than 6 months.

Location Information


Maryland
      University of Maryland Balt Prof School, Baltimore,  Maryland,  21201,  United States

Ohio
      Cincinnati Children's Hospital Med Ctr, Cincinnati,  Ohio,  45229,  United States

Texas
      Baylor College of Medicine - Houston TX (VTEU), Houston,  Texas,  77030-3498,  United States

More Information

Study ID Numbers:  04-098
Record last reviewed:  December 2004
Last Updated:  January 13, 2005
Record first received:  December 30, 2004
ClinicalTrials.gov Identifier:  NCT00100399
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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