Summary of findings 2. IPV‐OPV compared to IPV for preventing poliomyelitis.
| IPV‐OPV compared to IPV for preventing poliomyelitis | ||||||
| Patient or population: infants Setting: USA, UK, China, Guatemala, Chile, Bangladesh Intervention: IPV‐OPV Comparison: IPV | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with IPV | Risk with IPV‐OPV | |||||
| Paralytic wild polio cases at 4 years (Change level from IPV‐OPV to IPV) | −1.2 (−6.2 to 3.8) | −100% (−517% to 317%) |
(1 ITS) | ⊕⊝⊝⊝ Very lowa | Re‐analysis considering the year of schedule change as transition period | |
| Vaccine‐associated paralytic polio cases | ‐ | ‐ | ‐ | (0 studies) | ‐ | No data available |
|
Persons with protective humoral response (Range of follow‐up from 4.4 to 18 months) |
P1: 970 per 1000 | 972 per 1000 (961 to 980) | RR 1.00 (0.99 to 1.01) | 2858 (10 RCTs) | ⊕⊕⊕⊝ Moderateb |
IOO: −0 (−20 to + 20) persons IIO(O): 0 (−10 to + 10) persons IbOI: + 46 (0 to + 91) persons |
| P2: 960 per 1000 | 931 per 1000 (985 to 1000) | RR 0.97 (0.95 to 1.00) | 2907 (10 RCTs) | ⊕⊕⊝⊝ Lowb,c |
IbObO: −236 (−89 to −354) persons IOO: 0 (−39 to + 39) persons IbOI: −43 (−103 to + 17) persons |
|
| P3: 972 per 1000 | 962 per 1000 (953 to 982) | RR 0.99 (0.97 to 1.01) | 2620 (9 RCTs) | ⊕⊕⊕⊝ Moderateb |
IOO: −10 (−30 to + 20) persons IIO(O): −10 (−40 to + 20) persons IbOI: + 9 (−37 to + 47) persons |
|
| Comment: A nationwide ITS (Denmark) reported a median proportion of persons with protective humoral response for PV1, 2 and 3 as 82.06%, 91.94% and 76.67%, respectively, during IPV scheme; the proportions were higher during IPV‐OPV scheme: 98.44%; 97.67%; and 97.57%, respectively. | ||||||
|
Neutralising antibodies with 2 IPV doses Geometric mean titres (Follow‐up 5 months) |
P1 (IIO) P1 (IIbO) |
768 higher (+ 338 to + 1198)ME 867 higher (+ 479 to + 1254)ME |
‐ ‐ |
363 (2 RCTs) 127 (1 RCT) |
⊕⊕⊝⊝ Lowb,c ⊕⊕⊕⊝ Moderated |
IbObO: + 1521 (+ 1085 to + 1956) IOO: + 799 (+ 531 to + 1068) |
|
P2 (IIO) P2 (IIbO) |
2224 higher (−1146 to + 5594)LE 83 lower (−133 to −34)LE |
‐ ‐ |
362 (2 RCTs) 127 (1 RCT) |
⊕⊕⊝⊝ Very lowa,b,e ⊕⊕⊕⊝ Moderated |
IbObO: −126 (−175 to −77) IOO: + 142 (+ 58 to + 227) |
|
|
P3 (IIO) P3 (IIbO) |
185 higher (−212 to + 581)SE 698 higher (+ 301 to + 1096)SE |
‐ | 360 (2 RCTs) 127 (1 RCT) |
⊕⊕⊝⊝ Very lowa,b,c ⊕⊕⊕⊝ Moderated |
IbObO: + 328 (+ 135 to + 520) IOO: + 110 (−78 to + 299) |
|
|
Persons with faecal polio excretion after OPV challenge (Range of follow‐up from 4.4 to 18 months) |
P1: 427 per 1000 | 222 per 1000 (60 to 841) | RR 0.52 (0.14 to 1.97) | 822 (2 RCTs) | ⊕⊝⊝⊝ Very lowa,b,c |
ibOI: −356 (−297 to −394) persons IIO/IIOO: + 7 (−72 to + 148) persons |
| P2: 572 per 1000 | 309 per 1000 (177 to 537) | RR 0.55 (0.31 to 0.94) | 1351 (3 RCTs) | ⊕⊕⊝⊝ Lowb,c |
ibOI/IIbO: + 7 (−72 to + 148) persons IIO/IIOO: −329 (−282 to −357) persons |
|
| P3: 450 per 1000 | 176 per 1000 (144 to 212) | RR 0.39 (0.32 to 0.47) | 822 (2 RCTs) | ⊕⊕⊕⊝ Moderateb |
ibOI: −233 (−170 to −274) persons IIO/IIOO: −470 (−392 to −533) persons |
|
| Vaccination coverage | ‐ | ‐ | ‐ | (0 studies) | ‐ | No data available |
|
Serious adverse events (≥ 1 symptom related to study drug or not) (Range of follow‐up from 5 to 7 months) |
94 per 1000 | 87 per 1000 (57 to 135) | RR 0.92 (0.60 to 1.43) | 1063 (2 RCTs) | ⊕⊕⊝⊝ Lowb,c | ‐ |
| *The risk in the intervention group (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). # 2 IPV doses (IIO) was selected as the main result for this outcome since it is the most frequent scheme. CI: Confidence interval; RR: Risk ratio; P1, P2, P3: Poliovirus Serotypes 1, 2, 3 respectively. | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect | ||||||
I = IPV, O = OPV, bO = bOPV (see detailed acronyms in Appendix 1).
aSerious imprecision: confidence interval limits include clinically important increase or reduction of the effect. bSerious study limitations: most studies have unclear risk of bias regarding random sequence generation and allocation concealment. cConsiderable heterogeneity but in the same direction. dSerious imprecision: only one study with low number of participants. eVery serious imprecision: confidence interval limits include a marked effect increase or reduction.