Win 1997.
| Methods | Open, randomised and controlled with 2 groups of healthy neonates | |
| Participants | Healthy male and female infants; age 5 to 8 weeks | |
| Interventions | DTPw‐HBV‐HIB and separate DTPw‐HBV and HIB. 3 doses given at 1.5, 3 and 5 months of age | |
| Outcomes | Immunogenicity (antibody concentrations by serological analysis) and adverse events ‐ reactogenicity | |
| Notes | Clinical Research and Development, SmithKline Beecham Biologicals, Rixensart, Belgium address reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Healthy neonates from Central Women's Hospital, Yangon, Myanmar. Neonates with an Apgar score of 7 or higher 5 minutes after birth and who had no concomitant administration of immunoglobulins were enrolled |
| Allocation concealment (selection bias) | Unclear risk | Randomly assigned to one of two groups |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Open |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 37 out of 286 did not complete the full vaccination course |
| Selective reporting (reporting bias) | Low risk | Demographic and reactogenicity data were collected from diary cards completed by parents or a study nurse on the day of vaccination and during the 3 days following each dose and transferred to a Standad Case Report Form by the investigator |
| Other bias | High risk | Recommendation should not be generalised, however, as the data from this study apply only to the 2 specified vaccines, TritanrixTM and HiberixTM alternative vaccines should be investigated with regards to non‐interference before use as syringe mixes |
DTPw: diphtheria, tetanus, whole cell pertussis HBV: hepatitis B virus HIB: H. influenzae type B IPV: inactivated polio virus ITT: intention‐to‐treat liqHIB: liquid H. influenzae type B lyoHIB: lyophilised HIB OPV: oral polio vaccine PRP‐T: polyribsylribitolphosphate, (vaccine conjugated to tetanus toxoid) RCT: randomised controlled trial SD: standard deviation WHO: World Health Organization