Key result
Two doses of an oral, attenuated human rotavirus vaccine demonstrated 80% efficacy against any rotavirus gastroenteritis and 95% against severe rotavirus gastroenteritis in healthy infants.
Why the study?
Does an oral, attenuated monovalent G1[P8] human rotavirus vaccine prevent rotavirus gastroenteritis in healthy infants?
Population
405 healthy infants in Mexico
Comparison
2 doses of an oral, attenuated monovalent G1[P8]… vs Placebo administered concurrently with…
Design
RCT, Randomly assigned to 1 of 3 vaccine groups or a placebo group
Follow-up
up to age 2 years
Authors
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Supports routine rotavirus vaccination in healthy infants; confirms high efficacy of two-dose oral attenuated vaccine in RCT.
RCT (n=405)
randomly assigned
No
Does an oral, attenuated monovalent G1[P8] human rotavirus vaccine prevent rotavirus gastroenteritis in healthy infants?
Effect estimate: 80% efficacy (any) and 95% efficacy (severe)
Two doses of an oral, attenuated monovalent G1[P8] human rotavirus vaccine were safe, immunogenic, and highly efficacious in preventing severe rotavirus gastroenteritis in healthy infants.
Ruiz‐Palacios et al. (2007) conducted an RCT in rotavirus gastroenteritis (n=405). oral, attenuated monovalent G1[P8] human rotavirus vaccine vs. placebo was evaluated on any and severe rotavirus gastroenteritis (80% efficacy (any) and 95% efficacy (severe)). Two doses of an oral, attenuated human rotavirus vaccine demonstrated 80% efficacy against any rotavirus gastroenteritis and 95% against severe rotavirus gastroenteritis in healthy infants.
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