Table 1

Quality assessment of rotavirus vaccine trials

Quality assessment
Summary of findings
Directness
No. of events
Effect
No. of studiesDesignLimitationsConsistencyGeneralizability to population of interestGeneralizability to intervention of interestInterventionControlRelative reduction (95% CI)Comments
Effectiveness against very severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)4325574% (35–90%)
Effectiveness against severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)15592661% (38–75%)
Effectiveness against rotavirus hospitalizations (moderate outcome-specific quality)
    One29Matched case controlNoneNAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)216125047% (22–64%)
    One20Matched case controlNoneNARural hospital in the Northern Territory of AustraliaMonovalent vaccine (−0.5)105857% (<0–83%)
Efficacy against severe rotavirus infection (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes5935889.1% (77.9–94.6%)Random effects meta-analysis
Efficacy against severe GI infection (moderate outcome-specific quality)
    Two30,31RCTNoneBorderline heterogeneity from meta-analysis (P = 0.07); all studies show benefitEurope and Latin AmericaAll studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes59880844.2% (32.8–53.7%)Random effects meta-analysis
Efficacy against rotavirus hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes3029092.7% (77.2–97.6%)Random effects meta-analysis
Efficacy against GI hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes>292>47756% (39–73%)Random effects meta-analysis
Efficacy against any rotavirus (moderate outcome-specific quality)
    Two4,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaOne of two studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes20360774.4% (63.2–82.2%)Random effects meta-analysis
Quality assessment
Summary of findings
Directness
No. of events
Effect
No. of studiesDesignLimitationsConsistencyGeneralizability to population of interestGeneralizability to intervention of interestInterventionControlRelative reduction (95% CI)Comments
Effectiveness against very severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)4325574% (35–90%)
Effectiveness against severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)15592661% (38–75%)
Effectiveness against rotavirus hospitalizations (moderate outcome-specific quality)
    One29Matched case controlNoneNAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)216125047% (22–64%)
    One20Matched case controlNoneNARural hospital in the Northern Territory of AustraliaMonovalent vaccine (−0.5)105857% (<0–83%)
Efficacy against severe rotavirus infection (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes5935889.1% (77.9–94.6%)Random effects meta-analysis
Efficacy against severe GI infection (moderate outcome-specific quality)
    Two30,31RCTNoneBorderline heterogeneity from meta-analysis (P = 0.07); all studies show benefitEurope and Latin AmericaAll studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes59880844.2% (32.8–53.7%)Random effects meta-analysis
Efficacy against rotavirus hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes3029092.7% (77.2–97.6%)Random effects meta-analysis
Efficacy against GI hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes>292>47756% (39–73%)Random effects meta-analysis
Efficacy against any rotavirus (moderate outcome-specific quality)
    Two4,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaOne of two studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes20360774.4% (63.2–82.2%)Random effects meta-analysis

RCT: randomized controlled trial.

Table 1

Quality assessment of rotavirus vaccine trials

Quality assessment
Summary of findings
Directness
No. of events
Effect
No. of studiesDesignLimitationsConsistencyGeneralizability to population of interestGeneralizability to intervention of interestInterventionControlRelative reduction (95% CI)Comments
Effectiveness against very severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)4325574% (35–90%)
Effectiveness against severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)15592661% (38–75%)
Effectiveness against rotavirus hospitalizations (moderate outcome-specific quality)
    One29Matched case controlNoneNAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)216125047% (22–64%)
    One20Matched case controlNoneNARural hospital in the Northern Territory of AustraliaMonovalent vaccine (−0.5)105857% (<0–83%)
Efficacy against severe rotavirus infection (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes5935889.1% (77.9–94.6%)Random effects meta-analysis
Efficacy against severe GI infection (moderate outcome-specific quality)
    Two30,31RCTNoneBorderline heterogeneity from meta-analysis (P = 0.07); all studies show benefitEurope and Latin AmericaAll studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes59880844.2% (32.8–53.7%)Random effects meta-analysis
Efficacy against rotavirus hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes3029092.7% (77.2–97.6%)Random effects meta-analysis
Efficacy against GI hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes>292>47756% (39–73%)Random effects meta-analysis
Efficacy against any rotavirus (moderate outcome-specific quality)
    Two4,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaOne of two studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes20360774.4% (63.2–82.2%)Random effects meta-analysis
Quality assessment
Summary of findings
Directness
No. of events
Effect
No. of studiesDesignLimitationsConsistencyGeneralizability to population of interestGeneralizability to intervention of interestInterventionControlRelative reduction (95% CI)Comments
Effectiveness against very severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)4325574% (35–90%)
Effectiveness against severe rotavirus infection (moderate/low outcome-specific quality)
    One29Matched case controlHospital-based surveillance for cases (−0.5)NAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)15592661% (38–75%)
Effectiveness against rotavirus hospitalizations (moderate outcome-specific quality)
    One29Matched case controlNoneNAUrban and peri-urban hospitals in Nicaragua (−0.5)Pentavalent vaccine (−0.5)216125047% (22–64%)
    One20Matched case controlNoneNARural hospital in the Northern Territory of AustraliaMonovalent vaccine (−0.5)105857% (<0–83%)
Efficacy against severe rotavirus infection (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes5935889.1% (77.9–94.6%)Random effects meta-analysis
Efficacy against severe GI infection (moderate outcome-specific quality)
    Two30,31RCTNoneBorderline heterogeneity from meta-analysis (P = 0.07); all studies show benefitEurope and Latin AmericaAll studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes59880844.2% (32.8–53.7%)Random effects meta-analysis
Efficacy against rotavirus hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (−0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes3029092.7% (77.2–97.6%)Random effects meta-analysis
Efficacy against GI hospitalizations (moderate outcome-specific quality)
    Three4,30,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaTwo of three studies used monovalent vaccine; one used pentavalent. No co-interventions with potential to impact rotavirus outcomes>292>47756% (39–73%)Random effects meta-analysis
Efficacy against any rotavirus (moderate outcome-specific quality)
    Two4,31RCTNoneHeterogeneity from meta-analysis (0.5); all studies show benefitUSA, Europe and Latin AmericaOne of two studies used monovalent vaccine. No co-interventions with potential to impact rotavirus outcomes20360774.4% (63.2–82.2%)Random effects meta-analysis

RCT: randomized controlled trial.

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