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Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults - Article


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Avian Influenza

Avian flu; Bird flu; Bird flu (avian influenza); H5n1

Clinical Trial: Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults

This study is currently recruiting patients.

Sponsored by: MedImmune, Inc.
Information provided by: MedImmune, Inc.

Purpose

This trial will assess the safety of FluMist vaccination, the rates of medically attended events (MAEs) in FluMist recipients [including serious adverse events (SAEs), anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza] will be compared to rates in multiple non-randomized control groups.
Condition Intervention Phase
Healthy
Influenza
  Vaccine: FluMist
 Phase IV

MedlinePlus related topics:  Influenza

Study Type: Observational
Study Design: Natural History

Eligibility

Ages Eligible for Study:  5 Years   -   49 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • 5-49 years of age
  • Members of the Kaiser Permanente Health Care Plan within Kaiser Permanente of Northern California and Permanente of Colorado

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00113880

Laurie Aukes      (510) 271-5947 (Coord) 

California
      Kaiser Permanente Pediactrics, Fresno,  California,  93726,  United States; Recruiting
Barbara Handly  559-448-4830 
Steven Black, M.D.,  Principal Investigator

      Kaiser Permanente, Davis,  California,  95616,  United States; Recruiting
Michael Kinder  530-757-4148 
Steven Black, M.D.,  Principal Investigator

      Kaiser Pediatric Injections, Fairfield,  California,  94533,  United States; Recruiting
Diane Long  707-453-5481 
Julie Duke  707-427-4518 
Steven Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Fremont,  California,  94543,  United States; Recruiting
Rosa Miranda  510-248-3150 
Martha Alvarez, LVN  510-248-3825 
Steven Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Gilroy,  California,  93726,  United States; Recruiting
Kenneth Cheng, Pharm.  408-848-7028 
Krista Lund  559-448-4830 
Steven Black, M.D.,  Principal Investigator

      Kaiser Pediatric Injection Station, Hayward,  California,  94545,  United States; Recruiting
Linda Church  510-784-4550 
Steven Black, M.D.,  Principal Investigator

      Kaiser Permanente Adult Injection, Fremont,  California,  94538,  United States; Recruiting
Yvonne Jung  510-248-3972 
Jennifer Realin  510-248-5323 
Steven Black, M.D.,  Principal Investigator

      Kaiser Permanente Inpatient Pharmacy, Fresno,  California,  93720,  United States; Recruiting
Scott Shimamoto, PharmD  559-448-3305 
Michelle Hanrahan, RN  559-448-4962 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Alameda,  California,  94501,  United States; Recruiting
Alice Lin  510-752-9076 
Claudia Jangels  510-752-9092 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Antioch,  California,  94509,  United States; Recruiting
Debra Galloway  925-779-4323 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Clovis,  California,  93611,  United States; Recruiting
Pauline Hutton  559-324-5518 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Davis,  California,  95616,  United States; Recruiting
Bruno Kochis, LVN  650-301-4509 
Diane Heckenberg, LVN  650-301-4509 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Antioch,  California,  94531,  United States; Recruiting
Denise Quinn  925-813-3325 
Gail Raymond  925-813-3310 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente-Pediatrics, Folsom,  California,  95630,  United States; Recruiting
Lisa Lackey, RN  916-817-5403 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Pediactric Injection Station, Hayward,  California,  94545,  United States; Recruiting
Linda Church  510-784-4550 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Pediatric Injection Station, Livermore,  California,  94551,  United States; Recruiting
Pat Baker, LVN  925-243-4328 
Ann Conroy  925-243-4328 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Injection Clinic, Manteca,  California,  95337,  United States; Recruiting
Cathy Osnaya  209-557-1634 
Eliosa Salvador  209-557-1634 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Martinez,  California,  94553,  United States; Recruiting
Marilyn Blanchard  925-372-1607 
Patti Ruff  925-372-1318 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Milpitas,  California,  95035,  United States; Recruiting
Elisa Reyes  408-945-2789 
Mary Lee Olson  408-945-6177 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Injection Clinic, Modesto,  California,  95356,  United States; Recruiting
Angela Pace  209-557-1634 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Mountain View,  California,  95356,  United States; Recruiting
Barbara French  209-557-6186 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Napa,  California,  94558,  United States; Recruiting
Kitty Latham  707-258-4456 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Novato,  California,  94945,  United States; Recruiting
Francis Rosario  415-899-7548 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Oakland,  California,  94611,  United States; Recruiting
Cheryl Younger, LVN  510-752-1454 
Dianne Groves  510-752-7846 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Injection Clinic, Oakland,  California,  94611,  United States; Recruiting
Margie Jackson, LVN  510-752-7419 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Employee Health, Oakland,  California,  94611,  United States; Recruiting
Elaine Mazer, NP  510-752-7790 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Walnut Creek,  California,  94598,  United States; Recruiting
Margaret Franchetti  925-295-4429 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Employee Health, Oakland,  California,  94611,  United States; Recruiting
Elaine Mazer, NP  510-752-7790 
Stephen Brown, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Petaluma,  California,  94954,  United States; Recruiting
Kathy Rice  707-765-3472 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Pleasanton,  California,  94588,  United States; Recruiting
Carol Hansen  925-847-5608 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Rancho Cordova,  California,  95670,  United States; Recruiting
Vicki McFarlin, M.D.  916-631-2515 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Redwood City,  California,  94063,  United States; Recruiting
Maryann Gonzales  650-299-5068 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Richmond,  California,  94804,  United States; Recruiting
Sandy Fletcher  510-307-2523 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Roseville,  California,  95661,  United States; Recruiting
Patricia Pitts  916-784-6493 
Stephen Black,  Principal Investigator

      Kaiser Permanente, Sacramento,  California,  95815,  United States; Recruiting
Nan Osterholt, LVN  916-614-4845 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Inpatient Pharmacy, Redwood City,  California,  94063,  United States; Recruiting
Susanna Chan, Inpatient Inv.Tech  650-299-3567 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Adult Injection Clinic, Richmond,  California,  94804,  United States; Recruiting
Liz Carter  510-307-2335 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Roseville,  California,  95661,  United States; Recruiting
Kim Blair  916-746-3946 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, San Francisco,  California,  94115,  United States; Recruiting
Yolando Chiu  415-833-4893 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, San Rafael,  California,  94901,  United States; Recruiting
Lynn Reier  415-444-2160 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Adult Medicine, Santa Clara,  California,  95051,  United States; Recruiting
Kathleen Fitzsimmons  408-236-4511 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Santa Rosa,  California,  95403,  United States; Recruiting
Karen Visser, RN  707-566-5276 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Infectious Disease, Santa Rosa,  California,  95403,  United States; Recruiting
Audrey Baker  707-571-4146 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Employee Health, Santa Rosa,  California,  95403,  United States; Recruiting
Marcie Stock  707-571-3683 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Pediatric Injection Clinic, San Jose,  California,  95199,  United States; Recruiting
Bonnie Bradley  408-972-7568 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Pediatric Adult Medicine, San Jose,  California,  95199,  United States; Recruiting
Carolyn Pels  408-972-6436 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Selma,  California,  93662,  United States; Recruiting
Betty Andronicous, RN  559-898-4076 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Pediatric Injection Station, Sacramento,  California,  95823,  United States; Recruiting
Estela Rabara  916-688-2554 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Medicine Dept., Sacramento,  California,  95823,  United States; Recruiting
Jan Lanston  916-688-2827 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Injection/Allergy, Stockton,  California,  95210,  United States; Recruiting
GeorgAnn Greissinger, NP  209-476-3770 

      Kaiser Pediatric Injection Room, Vacaville,  California,  95688,  United States; Recruiting
Mary Chatman  707-453-5414 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatric Injections, Vallejo,  California,  94589,  United States; Recruiting
Erin Liggans  707-651-3357 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Vallejo,  California,  94589,  United States; Recruiting
Madeline Ibrahim, RN  707-651-3329 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Pediatrics, Walnut Creek,  California,  94596,  United States; Recruiting
Lana Schumacher  925-295-5636 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente Regional Employee Health, Oakland,  California,  94612,  United States; Recruiting
Marcia Castillo, LVN  510-987-1954 
Stephen Black, M.D.,  Principal Investigator

Colorado
      Kaiser Permanente Arapahoe, Littleton,  Colorado,  80122,  United States; Recruiting
Tammy Sabad  303-850-5839 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Aurora Centrepoint, Aurora,  Colorado,  80012,  United States; Recruiting
Tim Woodworth  303-614-7333 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Boulder, Boulder,  Colorado,  80304,  United States; Recruiting
Pam Honiotes  303-440-2699 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Baseline, Boulder,  Colorado,  80302,  United States; Recruiting
Pam Ingram  303-554-5164 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Boulder, Boulder,  Colorado,  80304,  United States; Recruiting
Pam Honiotes  303-440-2699 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Broomfield, Broomfield,  Colorado,  80020,  United States; Recruiting
Rita Williams  303-460-3931 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, East, Denver,  Colorado,  80231,  United States; Recruiting
Irma Smith  303-360-1253 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Englewood, Englewood,  Colorado,  80110,  United States; Recruiting
Julie Betschart  303-788-1119 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Hidden Lake, Arvada,  Colorado,  80003,  United States; Recruiting
Marti Johnson  303-657-6777 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Lakewood, Lakewood,  Colorado,  80226,  United States; Recruiting
Cindy Hendrickson  303-239-7256 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Longmont Primary Care, Longmont,  Colorado,  80501,  United States; Recruiting
Pam Strahan, RN  303-678-3236 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Skyline, Denver,  Colorado,  80205,  United States; Recruiting
Margaret Salamanaca  303-764-4995 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Smoky Hill, Aurora,  Colorado,  80015,  United States; Recruiting
Teresa  303-699-3645 
Stephen Black, M.D.,  Principal Investigator

      Kaiser Permanente, Southwest, Littleton,  Colorado,  80123,  United States; Recruiting
Neal Goolsby  303-972-5038 
Steven Black,, M.D.,  Principal Investigator

      Kaiser Permanente, Wheatridge, Wheatridge,  Colorado,  80033,  United States; Recruiting
Alexia Lentz  303-421-5040 
Stephen Black,, M.D.,  Principal Investigator

      Kaiser Permanente, Westminster, Westminster,  Colorado,  80234,  United States; Recruiting
Paul Clarke  303-457-6565 
Stephen Black, M.D.,  Principal Investigator

More Information

Study ID Numbers:  MI-FM025
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 10, 2005
ClinicalTrials.gov Identifier:  NCT00113880
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05


Source: ClinicalTrials.gov
Cache Date: July 6, 2005


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