Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT00983606
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT00983606
Study Brief:
Protocol Section:
NCT00983606