Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children

Exclusion Criteria

• •Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
• •Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
• •Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product.
• •Previous serious vaccine-associated AE or anaphylactic reaction
• •Known hypersensitivity to any vaccine component
• •Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
• •Member of a household that includes an immunocompromised individual or infants less than 6 months of age, other than a study participant
• •Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Note: children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
• •Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients
• •Major congenital malformations including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
• •Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product.
• •Previous serious vaccine-associated AE or anaphylactic reaction
• •Known hypersensitivity to any vaccine component
• •Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
• •Member of a household that includes an immunocompromised individual or infants less than 6 months of age
• •Attends daycare with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
• •Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids or bone marrow/solid organ transplant recipients.
• •Major congenital malformations including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders.
• •Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product.
• •Previous serious vaccine-associated AE or anaphylactic reaction.
• •Known hypersensitivity to any vaccine component.
• •Lung or heart disease, including any wheezing event or reactive airway disease. Subjects with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled.
• •Member of a household that includes an immunocompromised individual or infants less than 4 months of age.
• •Attends daycare with infants less than 4 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
• •The following are temporary or self-limiting conditions, and once resolved, the subject may be enrolled, if otherwise eligible. If the period of temporary exclusion is greater than 42 days, seronegative children will need to be rescreened for levels of RSV neutralizing antibody.
• •Fever (rectal temperature of greater than or equal to 100.4°F \[38°C\]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis) or nasal congestion significant enough to interfere with successful vaccination, or otitis media
• •Subject has received any killed vaccine or live attenuated rotavirus vaccine within 14 days prior to inoculation, any other live vaccine within 28 days prior to inoculation, or gamma globulin (or other antibody products) within the past 3 months prior to inoculation.
• •Receipt of another investigational vaccine or investigational drug 28 days prior to receiving this investigational RSV vaccine
• •Has received antibiotics or systemic or nasal steroid therapy for acute illness within the previous 3 days prior to vaccination (steroid skin creams or lotions and topical antibiotics or antifungal preparations are permitted)
• •Has received salicylate (aspirin) or salicylate-containing products within 28 days prior to inoculation
• •Children born at less than 37 weeks gestation and less than 1 year of age
• •Currently enrolled in another RSV study.