Abstract
Co-administration of oral live-attenuated human rotavirus vaccine RIX4414 (Rotarix) and oral polio vaccine (OPV) was assessed. Healthy infants were randomised to receive 2-doses of either: RIX4414 or placebo co-administered with OPV (12 and 16 weeks of age); or RIX4414 or placebo given 15 days after OPV. After vaccination, 56.5-66.7% of RIX4414 and 18.6% of placebo recipients had seroconverted for rotavirus IgA. No significant differences between RIX4414 groups with or without OPV co-administration were observed. No statistically significant differences were observed between groups for polio seroprotection rates. RIX4414 vaccine was immunogenic when co-administered with OPV and did not interfere with OPV seroprotection rates.
Trial registration:
ClinicalTrials.gov NCT00139334.
Publication types
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Clinical Trial, Phase II
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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, Oral
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Antibodies, Viral / blood
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Antibody Formation
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Bangladesh / epidemiology
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Diarrhea / epidemiology
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Diarrhea / immunology
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Diarrhea / virology
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Double-Blind Method
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Drug Administration Schedule
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Female
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Gastroenteritis / epidemiology
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Gastroenteritis / etiology
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Gastroenteritis / immunology
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Humans
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Infant
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Male
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Poliomyelitis / immunology
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Poliovirus Vaccines / administration & dosage
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Poliovirus Vaccines / therapeutic use*
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Rotavirus Infections / epidemiology
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Rotavirus Infections / immunology*
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Rotavirus Vaccines / administration & dosage
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Rotavirus Vaccines / therapeutic use*
Substances
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Antibodies, Viral
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Poliovirus Vaccines
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Rotavirus Vaccines
Associated data
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ClinicalTrials.gov/NCT00139334