| Methods |
Open, multi‐centre, randomised trial |
| Participants |
Healthy male and female infants; age 8 to 16 weeks |
| Interventions |
DTPa‐HBV‐IPV/HIB compared to separate DTPa ‐ HBV ‐ IPV + HIB. 3 doses given to 2, 4 and 6 months of age |
| Outcomes |
Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity |
| Notes |
Supported by SmithKline Biologicals, Rixensart, Belgium |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Healthy infants from 12 private paediatric offices in Kiel, Germany |
| Allocation concealment (selection bias) |
Unclear risk |
Randomised |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Open |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
10 out of 359 failed to complete the study |
| Selective reporting (reporting bias) |
Low risk |
Parents documented the reactions for 4 days |
