Key result
Three doses of the RRV-TV vaccine provided 100% efficacy (95% CI 83-100; P<0.001) against hospitalization for rotavirus gastroenteritis over up to four years of follow-up.
Why the study?
Does the RRV-TV vaccine prevent severe rotavirus gastroenteritis requiring hospitalization or clinic visits in infants?
Population
2,398 infants in Finland, aged 2 to 7 months at enrollment.
Comparison
Rhesus-human reassortant rotavirus tetravalent… vs Placebo preparation administered orally in three…
Design
RCT, randomized, blinded initially, unblinded in the fourth rotavirus season
Follow-up
up to 4 rotavirus seasons (approximately 3-4 years)
Authors
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Supports routine RRV-TV vaccination in infants to prevent hospitalizations; extends RCT evidence of efficacy to four years.
RCT (n=2,398)
Blinded
Randomized
Yes
Does the RRV-TV vaccine prevent severe rotavirus gastroenteritis requiring hospitalization or clinic visits in infants?
Effect estimate: Vaccine efficacy 100% (95% CI 83-100)
Absolute Event Rate: 0% vs 1.66%
p-value: p=<0.001
The RRV-TV vaccine provides sustained 100% protection against severe rotavirus gastroenteritis requiring hospitalization for up to 3 years after vaccination in infants.
Joensuu et al. (1998) conducted an RCT in Rotavirus gastroenteritis (n=2,398). Rhesus-human reassortant rotavirus tetravalent (RRV-TV) vaccine vs. Placebo was evaluated on Hospitalization because of rotavirus gastroenteritis (Vaccine efficacy 100%, 95% CI 83-100, p=<0.001). Three doses of the RRV-TV vaccine provided 100% efficacy (95% CI 83-100; P<0.001) against hospitalization for rotavirus gastroenteritis over up to four years of follow-up.
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