Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children
NCT01254175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2014-12-03
Summary
Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.
Conditions
- Parainfluenza Virus 3, Human
Interventions
- BIOLOGICAL
-
rHPIV3cp45 Vaccine
10\^5 TCID\^50 of rHPIV3cp45 vaccine, delivered as nose drops
- BIOLOGICAL
-
Placebo Vaccine
Placebo vaccine, delivered as nose drops
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Coleen K. Cunningham, MD · Duke University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 36 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2012-02-29
- Completion
- 2012-02-29
Countries
- United States
- Puerto Rico
Study Locations
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