Abstract
The pentavalent human-bovine reassortant rotavirus vaccine is indicated as a 3-dose series with first dose administered orally at 6 to 12 weeks with subsequent doses at 4 to 10 week intervals. In pre-licensure phase III trials, the majority followed this schedule, but there were 2956 instances where infants received a dose of pentavalent human-bovine reassortant rotavirus vaccine/placebo >10 weeks after the previous dose. Among this subset, the efficacy against any severity of disease, the reduction in utilization of healthcare resources and the safety profile after vaccination were comparable with overall results.
Publication types
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Clinical Trial, Phase III
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Randomized Controlled Trial
MeSH terms
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Female
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Health Facilities / statistics & numerical data
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Humans
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Immunization, Secondary / methods*
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Infant
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Male
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Placebos / administration & dosage
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Reassortant Viruses / immunology
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Rotavirus / immunology
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Rotavirus Infections / pathology
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Rotavirus Infections / prevention & control
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Rotavirus Vaccines / administration & dosage
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Rotavirus Vaccines / adverse effects*
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Rotavirus Vaccines / immunology*
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Vaccination / methods*
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Vaccines, Attenuated / administration & dosage
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Vaccines, Attenuated / adverse effects
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Vaccines, Attenuated / immunology
Substances
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Placebos
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RotaTeq
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Rotavirus Vaccines
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Vaccines, Attenuated