| Methods |
Open, multi‐centre, randomised (1:1), parallel‐group design |
| Participants |
Healthy male and female infants; age 8 to 15 weeks |
| Interventions |
DTPw‐HBV mixed with HIB compared with DTPw‐HBV and HIB separate in opposite thighs. 3 doses given at 2, 4 and 6 months and booster at 18 months of age |
| Outcomes |
Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity |
| Notes |
This study was funded by SmithKline Beecham Biologicals |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Healthy male and female infants from centres in Mexico, Brazil, Panama, Venezuela and the Dominician Republic |
| Allocation concealment (selection bias) |
Unclear risk |
Randomised (1:1), parallel‐group design |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Open |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
382 out of 400 completed the primary vaccination phase |
| Selective reporting (reporting bias) |
Low risk |
Parents documented the reactions for 4 days. At each subsequent visit the investigator transcribed information from the diary cards onto the Case Report Form and asked about any other adverse experiences that occurred after the period covered by the diary card |
