April 19, 1995JAMA
Evaluation of rhesus rotavirus monovalent and tetravalent reassortant vaccines in US children. US Rotavirus Vaccine Efficacy Group
Key result
The tetravalent rhesus rotavirus vaccine reduced the incidence of rotavirus gastroenteritis over two seasons with a relative efficacy of 57% (98.3% CI 29-74%).
Why the study?
Does rhesus rotavirus monovalent or tetravalent reassortant vaccine reduce the incidence of rotavirus gastroenteritis in healthy infants?
Population
1006 healthy infants between 4 and 26 weeks of age in the United States
Comparison
Rhesus rotavirus monovalent or tetravalent… vs Placebo (three doses)
Design
RCT, double-masked
Follow-up
two rotavirus seasons (2 years)
Authors
Discussion
Loading...
Member takes
Implication
Supports routine infant vaccination; confirms benefit of tetravalent rhesus rotavirus vaccine over two seasons.
Study Design
Type
RCT (n=1,006)
Blinding
Double-blind
Multicenter
Yes
Structured PICO
Does rhesus rotavirus monovalent or tetravalent reassortant vaccine reduce the incidence of rotavirus gastroenteritis in healthy infants?
P
Population
1,006 healthy infants between 4 and 26 weeks of age, followed over two rotavirus seasons to evaluate monovalent and tetravalent rotavirus vaccines.
I
Intervention
Rhesus rotavirus monovalent or tetravalent reassortant vaccines (three doses)
C
Comparator
Placebo (three doses)
O
Outcome
Incidence of rotavirus gastroenteritis over two rotavirus seasons, and reactogenicity (incidence of fever, diarrhea, and/or vomiting for 5 days after each dose)hard clinical
Main Result
Effect estimate: Relative efficacy 57% (tetravalent) (95% CI 29% to 74%)
Both monovalent and tetravalent rhesus rotavirus vaccines safely reduced the incidence of rotavirus gastroenteritis in infants, with the tetravalent vaccine providing broader protection against non-serotype 1 strains in the second year.
Limitations
- Unclear whether the reduction in non-serotype 1 rotavirus disease represents serotype-specific protection or a difference in the duration of protection.
Cite This Study
David I. Bernstein (1995) conducted an RCT in Rotavirus gastroenteritis (n=1,006). Rhesus rotavirus monovalent and tetravalent reassortant vaccines vs. Placebo was evaluated on Incidence of rotavirus gastroenteritis after three doses over two rotavirus seasons (Relative efficacy 57% (tetravalent), 95% CI 29% to 74%). The tetravalent rhesus rotavirus vaccine reduced the incidence of rotavirus gastroenteritis over two seasons with a relative efficacy of 57% (98.3% CI 29-74%).