Anand 2015.
Methods |
Study design: open‐label, randomised trial Setting: Mirpur, an urban neighbourhood in Dhaka, Bangladesh Study dates: 2012 to 2013 |
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Participants |
Sample size: 975 infants recruited from 27 November 2012 to 30 November 2013 Age: median age = 44 days Sex: male = 462, female = 513 Dropouts/withdrawals: not reported Inclusion criteria: not reported Exclusion criteria: "(1) receipt of any polio vaccine before enrolment; (2) diagnosis or suspicion of immunodeficiency or a bleeding disorder; (3) known allergy to polio vaccines or constituents; (4) any acute illness such as vomiting, diarrhoea or infection immediately before enrolment; and (5) an infant who was part of a multiple birth" (quote) |
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Interventions |
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Outcomes |
Timing of outcome assessment: 6, 14, and 18 weeks |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: randomisation mentioned but not described |
Allocation concealment (selection bias) | Unclear risk | Comment: randomisation mentioned but 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; adverse events may be influenced |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 5.4% lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Comment: reported outcomes are the same as those reported in the trial register (NCT01813604) |
Other bias | Low risk | Comment: study seems to be free of other bias |
Conflict of interest | Low risk | Comment: funded by the Centers for Disease Control and Prevention. All study authors declare that they have no conflict of interest. |