Table 4 Quality assessment of vaccine trials for immunization against 鈥� Rotavirus
From: Vaccines for the prevention of diarrhea due to cholera, shigella, ETEC and rotavirus
| 听 | Quality Assessment | Summary of Findings | ||||||
|---|---|---|---|---|---|---|---|---|
| 听 | Directness | No of events | 听 | |||||
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鈥�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鈥�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鈥�64%) |
One | Matched case control | None | NA | Rural hospital in the Northern Territory of Australia | Monovalent vaccine | 10 | 58 | 57% (<0鈥�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 |