Abstract
A quadrivalent precursor to the pentavalent rotavirus vaccine candidate RotaTeq was evaluated in a 3-dose, 439-subject study. To determine immunogenicity, the quantity of rotavirus immunoglobulin A (IgA) in stool specimens obtained, at 1 of 10 study sites, from 37 placebo and 37 vaccine recipients was measured. None of the placebo recipients showed a clinically important (>/=3-fold) increase in stool rotavirus IgA, whereas 31 vaccine recipients showed an increase after at least 1 dose of vaccine. In total, 16, 19, and 15 vaccine recipients had increases after 1, 2, and 3 doses, respectively, indicating that a 3-dose regimen increased the immune response elicited by this vaccine.
Publication types
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Clinical Trial
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Animals
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Antibodies, Viral / analysis
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Antibodies, Viral / blood
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Cattle
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Dose-Response Relationship, Immunologic
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Feces / chemistry*
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Humans
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Immunoglobulin A / analysis*
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Immunoglobulin A / blood
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Infant
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Reassortant Viruses / immunology*
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Rotavirus / immunology*
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Rotavirus Infections / immunology
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Rotavirus Infections / prevention & control
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Rotavirus Vaccines / administration & dosage*
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Rotavirus Vaccines / immunology
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Vaccines, Attenuated / administration & dosage*
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Vaccines, Attenuated / immunology
Substances
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Antibodies, Viral
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Immunoglobulin A
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Rotavirus Vaccines
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Vaccines, Attenuated