Safety of and Immune Response to a Human Parainfluenza Virus Vaccine (rHPIV3cp45) in Healthy Infants

Completed · Phase 1 · Has a placebo group

Conditions studied: Paramyxoviridae Infections, Virus Diseases

In brief

Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.

Key facts

Study ID

NCT00308412

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

45

Starts

2006-06-01

Expected to finish

2010-04-01

Last updated by the study team

2010-07-16

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• Center for Immunization Research, Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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