A Phase 2 Study to Evaluate Immune Responses of FluMist®
NCT ID: NCT00461981
Last Updated: 2021-10-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2007-05-31
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist
NCT00231907
A Post Marking Study to Evaluate the Safety of FluMist in Children
NCT00569894
Immunologic Response to FluMist vs. Flucelvax
NCT03982069
Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program
NCT00192218
Comparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment
NCT00138385
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The secondary objective of this study is to describe the safety of FluMist and TIV in subjects 12 to \<36 months of age.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FluMist, Influenza Virus Vaccine Live
FluMist, Influenza Virus Vaccine Live, Intranasal
FluMist, Influenza Virus Vaccine Live
0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
TIV, Trivalent Inactivated Influenza Virus Vaccine
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular
TIV, Trivalent Inactivated Influenza Virus Vaccine
0.25 mL will be administered intramuscularly for each of two doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TIV, Trivalent Inactivated Influenza Virus Vaccine
0.25 mL will be administered intramuscularly for each of two doses
FluMist, Influenza Virus Vaccine Live
0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent and HIPAA authorization obtained from the subject's legal representative
* Ability of the subject's legal representative to understand and comply with the requirements of the study
* Subject's legal representative available by telephone
* Ability to complete follow-up period of 180 days after final study vaccination as required by the protocol
Exclusion Criteria
* History of hypersensitivity to gentamicin
* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
* Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination)
* History of Guillain-Barré syndrome
* Any prior history of wheezing or asthma
* Acute febrile (≥100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination
* Use of aspirin or aspirin-containing products within the 30 days prior to randomization, or expected receipt through 180 days after final study vaccination
* Receipt of any prior influenza vaccine
* Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected receipt through 35 days after final study vaccination
* Administration of any live virus vaccine, other than measles, mumps, rubella, and varicella-containing vaccine(s), within 30 days prior to randomization, or expected receipt through 30 days after final study vaccination
* Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization, or expected receipt within 14 days before or 14 days after either study vaccination
* Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after final study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
* Receipt of any blood product within 90 days prior to randomization, or expected receipt through 35 days after final study vaccination
* Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
* Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results
12 Months
35 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedImmune LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
MedImmune Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Allende, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Harvey Pediatrics
Jonesboro, Arkansas, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
NuLife Clinical Research
Anaheim, California, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Peak Medical Research, LLC
Owensboro, Kentucky, United States
Benchmark Research
Metairie, Louisiana, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Henderson Pediatrics
Henderson, Nevada, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Dayton Clinical Research
Dayton, Ohio, United States
Northeast Cincinnati Pediatric Asso., Inc.
Mason, Ohio, United States
Celia Reyes-Acuna, M.D.
Corpus Christi, Texas, United States
Allergy Immunology Research Center of North Texas
Dallas, Texas, United States
Healthcare Discoveries, Inc.
San Antonio, Texas, United States
Wee Care Pediatrics
Layton, Utah, United States
Bear Care Pediatrics
Ogden, Utah, United States
Advanced Pediatrics
Vienna, Virginia, United States
Pediatrics at the Beach
Virginia Beach, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MI-CP128
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.