Summary of findings for the main comparison. IPV‐OPV compared to OPV for preventing poliomyelitis.
| IPV‐OPV compared to OPV for preventing poliomyelitis | ||||||
| Patient or population: infants Setting: USA, UK, China, Thailand, Israel, Oman, Guatemala, Bangladesh Intervention: IPV‐OPV Comparison: OPV | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with OPV | Risk with IPV‐OPV | |||||
|
Paralytic wild polio cases (Change in slope at 3 years) |
−0.2 (−1.3 to 0.9) |
−21% (−137% to 95%) |
(1 ITS) | ⊕⊝⊝⊝ Very lowa | Re‐analysis considering the year of schedule change as transition period | |
|
Vaccine‐associated paralytic polio (VAPP) cases (Range of follow‐up from 2 to 15 years) |
6.6 cases per year | 3.0 cases per year | −54.3% | (1 USA nationwide UBA study) | ⊕⊕⊝⊝ Lowb |
OPV (1990‐6): 46 cases (0.34 cases per million of OPV doses) IPV‐OPV (1997‐9): 13 cases, none with IPV‐OPV or all‐IPV schedules |
| 7.64 cases per million newborns | 1.56 cases per million newborns | −80% | (1 Russian Federation nationwide UBA study) |
OPV (1998‐2007): 1 VAPP case per 1.59 million OPV doses IPV‐OPV (2008‐14): 1 case per 4.18 million doses |
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| 90 cases | 0 case | −100% | (1 Hungary nationwide UBA study) |
OPV (1959‐92): 90 cases IPV‐OPV (1992‐2006): 0 cases |
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|
Persons with protective humoral response (Range of follow‐up from 4.4 to 18 months) |
P1: 973 per 1000 | 973 per 1000 (963 to 982) | RR 1.00 (0.99 to 1.01) | 3189 (12 RCTs) |
⊕⊕⊕⊝ Moderatea | No important differences with other vaccination schemes |
| P2: 989 per 1000 #subgroup with 2 IPV doses | 989 per 1000 (979 to 999) | RR 1.00 (0.99 to 1.01) | 2361 (11 RCTs) | ⊕⊕⊝⊝ Lowa,d |
IIbO: 0 (−70 to + 70) persons IbObO vs tOPV: −210 (−38 to −344) persons IbObO vs bOPV: + 672 (± 428 to + 1018) persons |
|
| P3: 962 per 1000 | 953 per 1000 (933 to 972) | RR 0.99 (0.97 to 1.00) | 3184 (12 RCTs) |
IbObO: −300 (−180 to −400) persons IOO / IOOO: −19 (−39 to 0) persons IIO/IIOO/IIIO: −10 (−39 to 10) persons IOI: −9 (−47 to + 28) persons |
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|
Neutralising antibodies with 2 IPV doses Geometric mean titres (GMT) (Range of follow‐up from 5 to 16 months) |
P1 (IIO) | 244 lower (−827 to + 339)SE | ‐ | 795 (3 RCTs) | ⊕⊕⊝⊝ Lowa,c |
IbObO: + 362 (−330 to + 1054) IOO: −181 (−594 to 232) IIIOO / IIIO: + 439 (−355 to + 1233) |
|
P2 (IIO) P2 (IIbO) |
267 higher (−84 to + 619)SE 218 lower (−305 to −130)LE |
‐ ‐ |
667 (3 RCTs) 125 (1 RCT) |
⊕⊕⊝⊝ Lowa,c ⊕⊕⊕⊝ Moderatea |
IbObO: −260 (−347 to −174) IOO: + 29 (−22 to + 79) IIIOO/IIIO: + 486 (−698 to + 1670) |
|
|
P3 (IIO) P3 (IIbO) |
90 higher (+ 9 to + 171)SE 592 higher (+ 185 to + 998)SE |
‐ ‐ |
667 (3 RCTs) 125 (1 RCT) |
⊕⊕⊕⊝ Moderatea |
IbObO: + 221 (+ 10 to + 432) IOO: + 44 (−1.47 to + 90) IIIOO/IIIO: + 248 (−181 to + 677) |
|
|
Persons with polio faecal excretion after OPV challenge (Range of follow‐up from 4.4 to 18 months) |
P1: 86 per 1000 | 193 per 1000 (60 to 613) | RR 2.24 (0.70 to 7.12) | 916 (2 studies) | ⊕⊕⊝⊝ Lowc,d | ‐ |
| P2: 279 per 1000 | 497 per 1000 (416 to 598) | RR 1.78 (1.49 to 2.14) | 916 (2 RCTs) | ⊕⊕⊕⊝ Moderatec | ||
| P3: 74 per 1000 | 173 per 1000 (108 to 276) | RR 2.35 (1.47 to 3.76) | 916 (2 RCTs) | |||
|
Vaccination coverage (Follow‐up 24 months) |
91.9% | 92.4% |
RR 1.01 (0.96 to 1.06) |
(1 ITS) | ⊕⊕⊝⊝ Low | ‐ |
|
Serious adverse events (classified by MedDRA) (Range of follow‐up from 5 to 16 months) |
48 per 1000 | 42 per 1000 (26 to 75) | RR 0.88 (0.46 to 1.70) | 1948 (4 RCTs) | ⊕⊕⊝⊝ Lowa,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 subgroup for this outcome since it is the most studied scheme CI: Confidence interval; RR: Risk ratio; P1, P2, P3: Poliovirus Serotypes 1, 2, 3 respectively; SE: Small effect; ME; Moderate effect.LE: Large effect | ||||||
| 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 study limitations: most studies have unclear risk of bias regarding random sequence generation and allocation concealment. bThese are data from quasi‐experimental studies and therefore evidence was graded as low, we have not downgraded or upgraded the evidence. cSerious imprecision: confidence interval limits include clinically important increase or reduction of the effect. dSerious inconsistency: considerable heterogeneity but in the same direction.