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

West 2001.

Methods Study design: open‐label, randomised trial
Setting: 3 sites, USA
Study dates: not reported
Participants Sample size: 126 healthy infants
Dropouts/withdrawals: 5 infants did not receive all 3 vaccines.
Age: not reported
Sex: male = 72, female = 54
Inclusion criteria: "Healthy infants approximately 2 months of age, who had previously received a dose of monovalent HB vaccine shortly after birth and had a negative history for both Hib disease and HBV infection, were recruited for the study" (quote)
Exclusion criteria: not reported
Interventions 2 treatment groups one in which infants were given diphtheria‐tetanus‐pertussis whole cell vaccine (DTP) + IPV at two months followed by two OPV doses and the other group received DTP + OPV at 2 months followed by two further OPV doses
  • Group 1 (DTP + IPV): (n = NR): IOO at 2, 4, 6, months

  • Group 2 (DTP + OPV): (n = NR): OOO at 2, 4, 6, months

Outcomes
  • Antibody responses against poliovirus types 1, 2 and 3

  • Adverse events. Parents or guardians were given report cards and asked to record daily any injection site or systemic adverse events.


Timing of outcome assessment: 6 months
Follow‐up: 14 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Infants were randomly allocated (1 : 1) to 1 of 2 treatment groups designated DTP/IPV and DTP+OPV"
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 Unclear risk Comment: not reported
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 This study was supported financially by the Merck Research Laboratories.