Jain 1997.
| Methods |
Study design: open‐label, randomised trial Setting: Tel Aviv, Israel Study dates: not reported |
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| Participants |
Sample size: 150 neonates Dropouts/withdrawals: 45 neonates; 25 from group II and 20 from group III Age: neonates Sex: not reported Inclusion criteria: healthy term, appropriate for date, newborns Exclusion criteria: newborns with significant problems during the first week of life |
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| Interventions |
Group IA (n = 25): III, at birth, 1.5 and 2.5 months Group IB (n = 25): IOOO, at birth, 1.5, 2.5 and 3.5 months Group II (n = 50): OOOO, at birth, 1.5, 2.5 and 3.5 months Group III (n = 50): OOO at 1.5, 2.5 and 3.5 months tOPV was obtained from Central Government Hospital supply. Each batch of the vaccine was tested for potency at NICD. The IPV used was prepared at Merieux Institute, France. Each dose provides 40, 8 and 32 D antigen units against the three poliovirus types. |
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| Outcomes |
Timing of assessment: 6 weeks, 10 weeks and 20 weeks Follow‐up: 4.6 months |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "..all newborns who were randomly divided into three groups" Quote: "The babies in the three groups after drop outs were comparable as regards their age and sex distribution, feeding pattern socioeconomic status and pre immunization antibody titers." Comment: this description is insufficient to classify as high or low risk of bias |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: no blinding but performance is not likely to be influenced by lack of blinding in terms of intervention or co‐interventions |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: no blinding but objective outcome (antibody titres) is not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "A total of 45 neonates who dropped out from the study belonged to Group II (25) and Group III (20)." |
| Selective reporting (reporting bias) | Low risk | Comment: no evidence of selecting reporting |
| Other bias | Low risk | Comment: no evidence of other bias |
| Conflict of interest | Unclear risk | Comment: not described |