Comparative reactogenicity and parental acceptability of pertussis vaccines administered into the ventrogluteal area and anterolateral thigh in children aged 2, 4, 6 and 18 months.

The importance of site of injection of combined pertussis/diphtheria/tetanus vaccines was investigated in two single blind studies. In the pilot study, in which the research instrument was trialed, 283 children aged 2-18 months received whole cell pertussis vaccine (DTPw) by the intramuscular route either into the anterolateral thigh or the ventrogluteal site. In the larger randomised study, 566 children aged 2-18 months were similarly injected with acellular pertussis vaccine (DTPa). Adverse reactions monitored after 24h showed the same lower rates for both vaccines with ventrogluteal injection compared with anterolateral thigh injection for systemic reactions (irritability (P<0.0001), perceived fever (P<0.0001), persistent crying/screaming (P<0.0001) and local reactions (bruising (P<0.0001) and redness/swelling (P<0.0001)). The Haemophilus influenzae type b vaccine (HibTITER) given concurrently in the contralateral site to the pertussis vaccine showed the same lower rates in both studies for ventrogluteal injection compared with anterolateral thigh injection for local reactions (redness/swelling both studies (P<0.0001) and bruising DTPw study (P<0.0001) and DTPa study (P<0.0004)).Parental acceptability was greater (P<0.0001) in both studies for ventrogluteal injection compared with anterolateral thigh injection.

RCT Entities:   Population Interventions Outcomes