| Methods |
Open, randomised clinical trial |
| Participants |
Healthy male and female infants; no age reported |
| Interventions |
DTPw‐HBV‐HIB and separate DTP‐HBV and HIB when received hepatitis B vaccine at birth; 3 doses given at 6, 10 and 14 weeks of age |
| Outcomes |
Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity |
| Notes |
Funding for this study was provided by SmithKline Beecham Biologicals |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The study was conducted in healthy infants with an Apgar score of 7 or higher at birth |
| Allocation concealment (selection bias) |
Unclear risk |
Randomised trial ‐ no details |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Open trial |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Only 8 out of 148 did not complete |
| Selective reporting (reporting bias) |
Low risk |
Parents documented the reactions for 4 days |
| Other bias |
Low risk |
|
