Clinical Trial: FLU-VACS

This study is not yet open for patient recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) May 2005

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00133523

Purpose

This study is a placebo-controlled trial to examine efficacies of the live attenuated and inactivated vaccines, and immune correlates of protection.
Condition Intervention Phase
Influenza
 Vaccine: FluMist
 Vaccine: Fluzone/Fluvirin
Phase IV

MedlinePlus related topics:  Influenza

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Comparative Study of Influenza Vaccines in Adults FLU-VACS

Further Study Details: 

Expected Total Enrollment:  1980

Expected completion: August 2007

This is a randomized, double-blinded, placebo-controlled, experimental epidemiologic study. The study will be conducted among 1,980 healthy adults aged 18-46 years and is expected to last 3 years. Participants will be randomly assigned to receive the live attenuated influenza vaccine (FluMist, Medimmune Vaccines) or the inactivated influenza vaccine (Fluzone, Aventis Pasteur, or Fluvirin, Evans/Chiron Vaccines) or placebo. Contemporary inactivated (parenteral administration) and live attenuated (intranasal administration) will be supplied by the manufacturers and administered according to manufacturers instructions (product label). Two placebo groups are planned; one that will resemble inactivated vaccine and given intranasally; both placebos will be physiological saline (for human use). The live attenuated vaccine and matched placebo (physiological saline) for intranasal administration will be pre-loaded in nasal spray devices and supplied by Medimmune Vaccines. In year one participants will be randomly assigned to receive one of the two licensed influenza vaccines (live-attenuated or inactivated) or placebo; in year two, receipt of vaccine or placebo will continue as assigned in the first year; in the third year, participants will continue to be followed but no interventions will be given. Participants will report occurrence of influenza-like illnesses and permit collection of throat swab specimens for virus isolation and identification. In study years 1 and 2, blood specimens for serologic studies will be collected immediately prior to vaccine receipt, 3-4 weeks post-vaccination and at the end of each influenza season; in year 3, blood specimens will be collected at pre- and post-season visits only. Data from this study will be analyzed by investigators at the University of Michigan, School of Public Health. For the purpose of analyses of the primary vaccine efficacy objectives, the official database will not be unblinded until a scientific review has been completed, protocol violators have been identified, and data have been declared complete. An Independent Data Monitoring Committee (IDMC) will be appointed and consist of two investigators with expertise in influenza and/or vaccine evaluation and one statistician. The IDMC will assist in determining when unblinding will occur, in decisions regarding the antigenic relatedness of vaccine and circulating strains, and if modifications to the study design are advisable in the third year of the study. All primary efficacy analyses and summaries will be performed on a per-protocol basis; the per-protocol dataset will consist of all enrolled participants who are randomized, receive study medications and who provide all planned blood specimens within a study year. Results for participants excluded from the primary analyses will be listed the reason for exclusion. All participants who are randomized and receive study medications, including participants excluded from the per-protocol analyses, will be summarized and presented as secondary analyses (intent-to-treat analyses). All participants who receive study medications will be included in the safety summaries. The primary objectives for this study are to evaluate the absolute efficacies of the live-attenuated and inactivated influenza vaccines, in preventing laboratory-confirmed symptomatic influenza caused by antigenically similarly or dissimilar (breadth of immunity) circulating influenza strains, and to evaluate duration of immune protection induced by vaccination.

Eligibility

Ages Eligible for Study:  18 Years   -   46 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Inclusion Criteria

  1. Persons must be adult men and women aged 18-46 years (have not reached 47th birthday)
  2. Persons must be able and willing to provide informed consent
  3. Persons must expect to reside in the study area during the 3-year study period and be interested in participating for 3 years
  4. Persons must be willing to receive the licensed live-attenuated vaccine (FluMist) or placebo given as a nasal spray, or the licensed inactivated influenza vaccine (Fluzone or Fluvirin) or placebo given as an intramuscular injection
  5. Persons must be willing to provide multiple blood specimens collected by venipuncture each year they are in the study. During each of the first two years of the study, blood specimens will be collected three times at the enrollment visit (immediately prior to administration of vaccine or placebo), at the first follow-up visit 3-4 weeks later, and at the end of the influenza season visit (approximately 4-6 months later); during the third year of the study, blood specimens will be collected twice only, at visits before and after the influenza season.
  6. Persons must be willing to notify study personnel in the event of influenza-like illness, to provide information on illness symptoms, and to permit collection of a throat culture (swab) specimen for laboratory studies.
  7. Persons must be willing to not receive an influenza vaccine for three years other than that (influenza vaccine or placebo) received as study medication

Exclusion Criteria:

Exclusion Criteria

  1. Persons with any health condition for which the inactivated vaccine is recommended (Advisory Committee on Immunization Practices ACIP) including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy.
  2. Persons who are currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination
  3. Persons with hypersensitivity to egg, egg protein, thimerosal (a preservative) or the antibiotic Gentamicin (also known as Garamycin)
  4. Persons who have had a prior serious reaction to influenza vaccine, or even had Guillan Barre syndrome
  5. Persons who are living in a household with or have direct occupational contact with immunosuppressed individuals (including health care workers with direct patient contact)
  6. Persons who have received an influenza vaccine for the 2004-05 influenza season or those who plan to receive an influenza vaccine during the three years of study other than that (influenza vaccine or placebo) received as study medication
  7. Persons who have received any other vaccine within one month prior to enrollment (may delay enrollment)
  8. Persons who have had a respiratory illness or illness with fever within 3 days of study enrollment (may delay enrollment)
  9. Persons who are participating in another research study involving any study medication
  10. Persons who have any condition that in the opinion of the investigator might interfere with the interpretation or evaluation of the study results

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00133523

Arnold Monto      (734) 764-5453 

Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109-2029,  United States

More Information

Study ID Numbers:  04-060
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133523
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23

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