| Methods |
Open‐label, multi‐centre, prospective, comparative trial |
| Participants |
Healthy male and female infants; age 63 days ± 7 days |
| Interventions |
DTPa‐IPV‐HBV‐HIB compared to separate DTPa‐IPV‐HIB and HBV vaccine. 3 doses given at 2, 4 and 6 months of age |
| Outcomes |
Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity |
| Notes |
This study was supported by a grant from Avintis Pasteur MSD |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Study was conducted in healthy infants born after 36 weeks of pregnancy with birth weight of > 2500 g by 70 paediatricians located in the Haute‐Normandie, Provence‐Alpes‐Cote d'azur and Rhone‐Alpes regions of France |
| Allocation concealment (selection bias) |
Low risk |
Randomly allocated according to a centralised list |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Open‐label study |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
166 out of 833 did not complete the study |
| Selective reporting (reporting bias) |
Low risk |
The reactogenicity profile was determined by describing the rates of immediate reactions, the rates of local and systemic adverse events within 15 min to 72 hours and the frequency of adverse events requiring a medical visit within 1 month of vaccination |
