| Methods |
Open, randomised, multi‐centre, comparative phase III clinical trial |
| Participants |
Healthy male and female infants; age 9.3 ± 1.4 weeks (range 5 to 16) |
| Interventions |
DTPa‐HBV‐HIB and separate DTPa‐HBV and HIB with OPV simultaneously. 3 doses given at 2, 4 and 6 months of age |
| Outcomes |
Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity |
| Notes |
Study supported by a grant from GlaskoSmithKline Biologicals, Rixensart, Belgium |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Healthy infants were recruited in 11 centres from Greece, Spain and Switzerland |
| Allocation concealment (selection bias) |
Unclear risk |
The randomizations was made using an algorithm of pseudo‐random numbers. Subjects were allocated to the two groups according to a 3:1 ratio |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Open trial |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
30 out of 885 did not complete the full vaccination course |
| Selective reporting (reporting bias) |
Low risk |
Parents documented the reactions for 4 days |
| Other bias |
High risk |
The immunogenicity subset comprised 95 infants. The limited sample size of the immunogenicity results places a limitation on the conclusions that can be drawn |
