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. 2019 Dec 5;2019(12):CD011260. doi: 10.1002/14651858.CD011260.pub2

Anand 2015.

Methods Study design: open‐label, randomised trial
Setting: Mirpur, an urban neighbourhood in Dhaka, Bangladesh
Study dates: 2012 to 2013
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)
Interventions
  • Group A (n = 203): OOO (tOPV) at 1.5, 2.5 and 3.5 months

  • Group B (n = 200): OOO (bOPV) at 1.5, 2.5 and 3.5 months

  • Group C (n = 156): II (IPV intramuscular) at 1.5 and 3.5 months

  • Group D (n = 152): II (f‐IPV intradermal) at 1.5 and 3.5 months

  • Group E (n = 211): IOI (f‐IPV intradermal, bOPV, f‐IPV intradermal) at 1.5, 2.5 and 3.5 months, respectively

Outcomes
  • Immunogenicity: seroconversion at 18 weeks of age compared to 6 weeks of age of antibodies to poliovirus types 1, 2 and 3 at the Centers for Disease Control and Prevention (CDC), Atlanta, USA, using microneutralisation assay. Titres below a dilution of 1:8 were considered negative for presence of poliovirus antibodies. Seroconversion is defined as either seronegative participants (< 1:8 titres) who become seropositive (≥ 1:8) or participants who demonstrate a 4‐fold change in titres between two specimens (e.g. a change from 1:8 to 1:32)


Timing of outcome assessment: 6, 14, and 18 weeks
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.