A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children

Completed · Phase 2

Conditions studied: Healthy

In brief

Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.

Key facts

Study ID

NCT00344305

Run by

MedImmune LLC

People needed

200

Starts

2006-05-01

Expected to finish

2006-12-01

Last updated by the study team

2017-07-24

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, 6 months to less than 60 months of age (reached their 6th month but not yet reached their 5th year birthday) at the time of study vaccination
• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the participants parent/legal representative
• Ability of the participants parent/legal representative to understand and comply with the requirements of the study
• Participants parent/legal representative available by telephone
• Ability to complete follow-up period of 180 days after study vaccination as required by the protocol

You may not qualify if…

• History of hypersensitivity to any component of trivalent influenza virus vaccine live, intranasal, including egg or egg products, monosodium glutamate, or porcine gelatin
• History of hypersensitivity to gentamicin
• History of Guillain-Barré syndrome
• Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to study vaccination (i.e., children with recent persistent asthma were excluded); or history of severe persistent asthma according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report
• Acute febrile (greater than or equal to [>=] 100.0 degree Fahrenheit [°F] oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to study vaccination
• Any known immunosuppressive condition or immune deficiency disease (including human immunodeficiency virus [HIV] infection), or ongoing receipt of any immunosuppressive therapy
• Household contact who was immunocompromised (participants were also to avoid close contact with immunocompromised individuals for at least 21 days after study vaccination)
• Use of aspirin or aspirin-containing products within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination
• Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
• Use of any intranasal medication within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
• Administration of any live virus vaccine within the 30 days prior to study vaccination, or expected receipt through 30 days after study vaccination
• Administration of any inactivated (i.e., non-live) vaccine within the 14 days prior to study vaccination, or expected receipt through 14 days after study vaccination
• Receipt of any investigational agent within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert was permitted)
• Receipt of any blood product within the 90 days prior to study vaccination, or expected receipt through 28 days after study vaccination
• Family member or household contact who was 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 have interfered with evaluation of the vaccine or interpretation of study results

Where it is running

• Little Rock Allergy & Asthma Clinic, PA — Little Rock, Arkansas, United States
• Pediatric and Adolescent Medicine, PA (PAMPA) — Marietta, Georgia, United States
• Kentucky Pediatrics/Adult Research — Bardstown, Kentucky, United States
• Benchmark Research — Metairie, Louisiana, United States
• Health Sciences Research Center — Cortland, New York, United States
• Health Sciences Research Center — Elmira, New York, United States
• Regional Clinical Research Inc. — Endwell, New York, United States
• Grand Prairie Pediatrics & Allergy Clinic — Oklahoma City, Oklahoma, United States
• Primary Physicians Research , Inc — Pittsburgh, Pennsylvania, United States
• Med-Pro Research Inc. — Houston, Texas, United States
• Central Texas Health Research — New Braunfels, Texas, United States
• Benchmark Research — San Angelo, Texas, United States
• Wee Care Pediatrics — Layton, Utah, United States
• Utah Valley Pediatrics — Provo, Utah, United States
• PI-Coor Clinical Research, LLC — Burke, Virginia, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.