Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

Exclusion Criteria

• •2. Informed Consent Form signed by parent(s).
• •1. Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days).
• •2. Mechanical ventilation (including continuous positive airway pressure \[CPAP\]) at the time of enrollment.
• •3. Life expectancy less than 6 months.
• •4. Active respiratory illness, or other acute infection.
• •5. Known renal impairment, as determined by the investigator.
• •6. Known hepatic impairment, as determined by the investigator.
• •7. History of seizures (except neonatal seizures).
• •8. Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly).
• •9. Known immunodeficiency, as determined by the investigator.
• •10. Allergy to immunoglobulin products.
• •11. Prior receipt of RSV vaccine or prophylaxis (e.g., palivizumab or motavizumab), or administration of a product possibly containing RSV-neutralizing antibody within 100 days prior to enrollment (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin).
• •12. Participation in another clinical trial within 30 days prior to enrollment.
• •13. Previous enrollment in this trial.
• •14. For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.