An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants

Completed

Conditions studied: Healthy

In brief

The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.

Key facts

Study ID

NCT00983606

Run by

MedImmune LLC

People needed

3000

Starts

2009-09-01

Expected to finish

2011-07-01

Last updated by the study team

2012-11-14

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days GA)
• Age 6 months or less at the time of screening, and born in May 2009 through January 2010 for Season 1, or May 2010 through February 2011 for Season 2
• Written informed consent and any locally required authorization (eg, HIPAA), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures.

You may not qualify if…

• Receipt of any RSV prophylactic agent: at any time prior to study participation
• Participation in studies of investigational RSV prophylaxis or RSV therapeutic agents
• Presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects
• Any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Dothan, Alabama, United States
• Research Site — Greenville, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Prattville, Alabama, United States
• Research Site — Scottsboro, Alabama, United States
• Research Site — Selma, Alabama, United States
• Research Site — Sylacauga, Alabama, United States
• Research Site — Tuscaloosa, Alabama, United States
• Research Site — Chandler, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Prescott, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Benton, Arkansas, United States
• Research Site — Bentonville, Arkansas, United States
• Research Site — Fort Smith, Arkansas, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Chico, California, United States
• Research Site — Fountain Valley, California, United States
• Research Site — Fresno, California, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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