Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children

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 primary 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

NCT01021397

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

12

Starts

2009-11-01

Expected to finish

2011-12-01

Last updated by the study team

2013-01-03

Who can join

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

You may qualify if…

• Good general health
• HPIV3-uninfected
• 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 and inactivated vaccines
• 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

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 have received immunosuppressive therapy, including systemic corticosteroids within 30 days prior to study entry. 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 HPIV3 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 if participant is currently less than 12 months of age
• 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.
• Enrolled in another investigational drug or vaccine study from 30 days prior to study entry until the final follow-up blood draw

Where it is running

• Center for Immunization Research (CIR), Johns Hopkins School of Public Health — Baltimore, Maryland, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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