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Table 4 Quality assessment of vaccine trials for immunization against – Rotavirus

From: Vaccines for the prevention of diarrhea due to cholera, shigella, ETEC and rotavirus

  Quality Assessment Summary of Findings
  Directness No of events  
No of Studies Design Limitations Consistency Generalizability to population of interest Generalizability to intervention of interest Intervention Control Relative Risk (95% CI)
Effectiveness against very severe rotavirus infection: Moderate/low outcome-specific quality
One Matched case control Hospital-based surveillance for cases NA Urban and peri-urban hospitals in Nicaragua Pentavalent vaccine 43 255 74% (35–90%)
Effectiveness against severe rotavirus infection: Moderate/low outcome-specific quality
One Matched case control Hospital-based surveillance for cases NA Urban and peri-urban hospitals in Nicaragua Pentavalent vaccine 155 926 61% (38–75%)
Effectiveness against rotavirus hospitalizations: Moderate outcome-specific quality
One Matched case control None NA Urban and peri-urban hospitals in Nicaragua (-0.5) Pentavalent vaccine 216 1250 47% (22–64%)
One Matched case control None NA Rural hospital in the Northern Territory of Australia Monovalent vaccine 10 58 57% (<0–83%)
Efficacy against severe rotavirus infection: High outcome-specific quality
Eight RCT None Heterogeneity from meta-analysis all studies show benefit Four studies from developing and four from developed countries Two used Monovalent Vaccine 237 745 0.17 [0.09, 0.32]b
Efficacy against severe GI infection: Moderate outcome-specific quality
Six RCT None All studies show benefit Two from developed countries Two used Monovalent Vaccine 1328 1573 0.68 [0.57, 0.81]b
Efficacy against rotavirus hospitalizations: Moderate outcome-specific quality
Five RCT None All studies show benefit Four studies from developed countries Two used Monovalent Vaccine 46 329 0.11 [0.05, 0.27]b
Efficacy against GI hospitalizations: Moderate outcome-specific quality
Two RCT None All studies show benefit USA, Europe and Latin America Two of three studies used monovalent vaccine; one used pentavalent. 203 607 0.43 (0.21, 0.9)b
Efficacy against any rotavirus: High outcome-specific quality
Five RCT None All studies show benefit Four studies from developed countries One study used monovalent vaccine 586 1348 0.39 [0.25, 0.61]b
  1. a: Fixed Effect Model
  2. b: Random Effect Model