Summary of findings 4. RV5 compared to placebo for preventing rotavirus diarrhoea in high‐mortality countries.
| Patient or population: children Settings: high‐mortality countries (WHO strata D and E) Intervention: RV5 Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | RV5 | |||||
| Severe cases of rotavirus diarrhoea Follow‐up: up to 1 year | 30 per 1000 | 13 per 1000 (9 to 19) | RR 0.43 (0.29 to 0.62) | 5916 (2 studies) | ⊕⊕⊕⊕ high | RV5 reduces severe rotavirus diarrhoea compared to placebo at up to one year follow‐up. |
| Severe cases of rotavirus diarrhoea Follow‐up: up to 2 years | 63 per 1000 | 37 per 1000 (27 to 51) | RR 0.59 (0.43 to 0.82) | 5885 (2 studies) | ⊕⊕⊕⊕ high | RV5 reduces severe rotavirus diarrhoea compared to placebo at up to two years follow‐up. |
| Severe cases of all‐cause diarrhoea Follow‐up: up to 1 year | 77 per 1000 | 62 per 1000 (45 to 85) | RR 0.8 (0.58 to 1.11) | 4085 (1 study) | ⊕⊕⊕⊝
moderatea due to indirectness |
RV5 probably makes little or no difference to severe all‐cause diarrhoea compared to placebo at up to one year follow‐up. |
| Severe cases of all‐cause diarrhoea Follow‐up: up to 2 years | 130 per 1000 | 110 per 1000 (97 to 127) | RR 0.85 (0.75 to 0.98) | 5977 (2 studies) | ⊕⊕⊕⊕ high | RV5 slightly reduces severe all‐cause diarrhoea compared to placebo at up to two years follow‐up. |
| All‐cause death Follow‐up: 2 months to 2 years | 26 per 1000 | 23 per 1000 (17 to 32) | RR 0.92 (0.68 to 1.24) | 6806 (3 studies) | ⊕⊕⊝⊝
lowb due to imprecision |
RV5 may make little or no difference to all‐cause death compared to placebo. |
| All serious adverse events Follow‐up: 2 months to 2 years | 21 per 1000 | 19 per 1000 (14 to 27) | RR 0.92 (0.66 to 1.28) | 6830 (4 studies) | ⊕⊕⊕⊝
moderatec due to imprecision |
RV5 probably makes little or no difference to serious adverse events compared to placebo. |
| Serious adverse events: intussusception Follow‐up: 2 months to 2 years | See comment | See comment | Not estimable | 6588 (2 studies) | ⊕⊕⊝⊝
lowd due to imprecision |
No events were reported. RV5 may make little or no difference to intussusception compared to placebo. |
| *The basis for the assumed risk is the control group risk across studies included in the meta‐analysis. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High‐certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate‐certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low‐certainty: we are very uncertain about the estimate. | ||||||
aDowngraded by one for indirectness. Single trial conducted in three African countries (Mali, Ghana, and Kenya), so generalization to any high‐mortality country is difficult. bDowngraded by two for imprecision. These trials were not powered to detect an effect on mortality. cDowngraded by one for imprecision. The 95% CI includes both no effect and appreciable harm. dDowngraded by two for imprecision. There was a 1:10,000 to 1:32,000 increased risk of intussusception with a previous rotavirus vaccine (Bines 2005), so these trials were not powered to detect an association between RV1 and intussusception.