Summary of findings 5.
Rotavac compared to placebo for preventing rotavirus diarrhoea in high‐mortality countries
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Patient or population: children Settings: one high‐mortality country (India) (WHO stratum D) Intervention: Rotavac Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Rotavac | |||||
|
Severe cases of rotavirus diarrhoea follow‐up: up to 1 year |
31 per 1000 | 13 per 1000 (9 to 19) | RR 0.43 (0.30 to 0.60) | 6799 (1 study) | ⊕⊕⊕⊝ moderatea due to indirectness |
Rotavac 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 | 47 per 1000 | 21 per 1000 (16 to 28) | RR 0.46 (0.35 to 0.60) | 6541 (1 study) | ⊕⊕⊕⊝ moderatea due to indirectness |
Rotavac probably reduces severe rotavirus diarrhoea compared to placebo at up to two years follow‐up. |
|
Severe cases of all‐cause diarrhoea follow‐up: up to 2 years |
93 per 1000 | 78 per 1000 (66 to 91) | RR 0.84 (0.71 to 0.98) | 6799 (1 study) | ⊕⊕⊕⊝ moderatea due to indirectness |
Rotavac probably slightly reduces severe all‐cause diarrhoea compared to placebo at up to one year follow‐up. |
|
All‐cause death follow‐up: up to 2 years |
7 per 1000 | 6 per 1000 (4 to 11) | RR 0.92 (0.52 to 1.62) | 8155 (2 studies) | ⊕⊝⊝⊝ very lowb,c due to indirectness and imprecision |
We are uncertain whether Rotavac reduced all‐cause death as the certainty of the evidence is very low. |
|
All serious adverse events follow‐up: up to 2 years |
204 per 1000 | 189 per 1000 (173 to 208) | RR 0.93 (0.85 to 1.02) | 8210 (3 studies) | ⊕⊕⊕⊝ moderateb due to indirectness |
Rotavac probably makes little or no difference to serious adverse events compared to placebo. |
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Serious adverse events: intussusception follow‐up: up to 2 years |
1 per 1000 | 1 per 1000 (0 to 5) | RR 1.33 (0.35 to 5.02) | 8582 (4 studies) | ⊕⊝⊝⊝ very lowb,d due to indirectness and imprecision |
No events were reported in three of the four studies. We are uncertain whether Rotavac has an effect on intussusception as the certainty of the evidence is very low. |
| *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 India, so generalization to any high‐mortality country is difficult. bDowngraded by one for indirectness. All trials were conducted in India, so generalization to any high‐mortality country is difficult. 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), therefore, these trials were not powered to detect an association between Rotavac and intussusception.