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 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT00308412
Eligibility Criteria:
Inclusion Criteria for All Participants:
* Good general health
* Full term infant, born later than the 36th week of pregnancy
* Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
* Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus vaccine
* Available for the duration of the trial
* Parent or guardian reachable by telephone for post-immunization contact
* Parent or guardian willing to provide informed consent
* For Group 2 participants, serum hemagglutination-inhibiting (HAI) titers to HPIV3 of or less than 1:8
Exclusion Criteria:
* Known or suspected impairment of immunologic functions. Infants who are HIV infected, who are bone marrow or solid organ transplant recipients, or who are using immunosuppressive therapy, including systemic corticosteroids, are excluded. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
* Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
* Previously received PIV3 vaccine
* Previous serious vaccine-associated adverse event or anaphylactic reaction
* Known hypersensitivity to any vaccine component
* Lung or heart disease, including reactive airway disease. Infants with clinically insignificant cardiac abnormalities are not excluded. Infants or children who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months are not excluded.
* Born prematurely before the 37th week of pregnancy
* Member of a household containing immunocompromised individuals, pregnant caregivers, or infants less than 6 months of age
* Attends day care with infants less than 6 months of age
* Parent or guardian unable or unwilling to suspend daycare for 14 days following each immunization. More information on this criterion can be found in the protocol.
* Currently enrolled in another investigational drug or vaccine study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
36 Months
Study:
NCT00308412
Study Brief:
Protocol Section:
NCT00308412