Summary of findings 3.
RV5 compared to placebo for preventing rotavirus diarrhoea in low‐mortality countries
| Patient or population: children Settings: low‐mortality countries (WHO strata A and B) 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 | 17 per 1000 | 1 per 1000 (1 to 5) | RR 0.08 (0.03 to 0.22) | 4132 (5 studies) | ⊕⊕⊕⊝ moderatea due to imprecision |
RV5 probably 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 | 25 per 1000 | 4 per 1000 (2 to 10) | RR 0.18 (0.08 to 0.39) | 7318 (4 studies) | ⊕⊕⊕⊝ moderateb due to inconsistency |
RV5 probably reduces severe rotavirus diarrhoea compared to placebo at up to two years follow‐up. |
| Severe all‐cause diarrhoea Follow‐up: up to 1 year | ‐ | ‐ | ‐ | ‐ | ‐ | We found no studies that reported on this outcome in this setting |
| Severe all‐cause diarrhoea Follow‐up: up to 2 years | ‐ | ‐ | ‐ | ‐ | ‐ | We found no studies that reported on this outcome in this setting |
| All‐cause death Follow‐up: 2 months to 2 years | 1 per 1000 | 1 per 1000 (0 to 1) | RR 1.13 (0.65 to 1.96) | 77,642 (9 studies) | ⊕⊕⊝⊝ lowc 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 | 27 per 1000 | 25 per 1000 (23 to 28) | RR 0.93 (0.86 to 1.02) | 75,672 (8 studies) | ⊕⊕⊕⊕ high | RV5 makes little or no difference to serious adverse events compared to placebo. |
| Serious adverse events: intussusception Follow‐up: 2 months to 2 years | 1 per 1000 | 0 per 1000 (0 to 1) | RR 0.77 (0.41 to 1.45) | 78,907 (12 studies) | ⊕⊕⊝⊝ lowd due to imprecision |
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 imprecision. The total number of events was very low. bDowngraded by one for inconsistency. We found substantial heterogeneity (I2 statistic = 44%). Consistency was restored when removing the one study carried out only in a very low‐mortality (stratum A) country, with results then showing a slightly smaller effect (RR 0.22, 95% CI 0.13 to 0.36, 6291 participants, 3 studies). cDowngraded by two for imprecision. These trials were not powered to detect an effect on mortality. 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.