Abstract
A live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine was evaluated in healthy respiratory syncytial virus/parainfluenza virus type 3 seropositive children aged 1 to 9 years. Three cohorts of 40 children were randomized 1:1 to receive 10, 10, or 10 median tissue culture infectious dose50 MEDI-534 vaccine or placebo. The vaccine's safety profile was similar to placebo, no viral shedding was detected, and the vaccine was minimally immunogenic.
Trial registration:
ClinicalTrials.gov NCT00345670.
Publication types
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Clinical Trial, Phase I
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Administration, Intranasal
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Child
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Child, Preschool
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Feces / virology
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Female
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Human Experimentation
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Humans
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Infant
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Male
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Parainfluenza Vaccines / administration & dosage
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Parainfluenza Vaccines / adverse effects
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Parainfluenza Vaccines / immunology*
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Parainfluenza Virus 3, Human / immunology*
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Paramyxoviridae Infections / prevention & control*
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Placebos / administration & dosage
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Respiratory Syncytial Virus Infections / prevention & control*
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Respiratory Syncytial Virus Vaccines / administration & dosage
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Respiratory Syncytial Virus Vaccines / adverse effects
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Respiratory Syncytial Virus Vaccines / immunology*
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Respiratory Syncytial Viruses / immunology*
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Vaccines, Attenuated / administration & dosage
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Vaccines, Attenuated / adverse effects
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Vaccines, Attenuated / immunology
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Virus Shedding
Substances
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Parainfluenza Vaccines
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Placebos
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Respiratory Syncytial Virus Vaccines
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Vaccines, Attenuated
Associated data
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ClinicalTrials.gov/NCT00345670