| Methods |
Open, randomised trial |
| Participants |
Healthy male and female infants; age 13.2 weeks, range 8 to 12 weeks |
| Interventions |
DTPa‐HBV‐IPV/HIB compared to DTPa‐IPV/HIB and HBV in separate injections; 3 doses between 11 and 17 weeks of age |
| Outcomes |
Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity |
| Notes |
The study was supported by a grant from GlaskoSmithKline Biologicals, Rixensart, Belgium |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The study was conducted in healthy infants in 8 regions in Slovakia |
| Allocation concealment (selection bias) |
Unclear risk |
Randomised study without details |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Open study |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
309 out of 312 completed |
| Selective reporting (reporting bias) |
Low risk |
Parents documented the reactions for 4 days |
| Other bias |
Low risk |
|
