| Methods |
Prospective, randomised multi‐centre trial. 3 to 1 to group 1 and 2 respectively, comparing combined injections with three separate simultaneous injections |
| Participants |
Healthy male and female infants; age 6 to 12 weeks |
| Interventions |
DTPa‐HBV‐PRP‐T and booster of HIB. OPV was administered to all vaccinees in both groups concurrently at 2, 4 and 6 months of age. 3 doses given at 2, 4 and 6 months of age and booster of PRP conjugate vaccine to group 1 (combined) with low levels of antibody at 9 to 13 months of age |
| Outcomes |
Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity |
| Notes |
This work was supported by SmithKline Beecham Biologicals (Philadelphia) and the National Institute of Health (AI45248) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Healthy infants were recruited for a multi‐centre (3 groups in NY, Pittsburgh and VA), prospective, randomised trial |
| Allocation concealment (selection bias) |
Unclear risk |
Infants were randomised three to one to groups 1 and 2 respectively |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No details |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No data |
| Selective reporting (reporting bias) |
Unclear risk |
No data |
