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
|
|
Outcomes |
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. |