Immunogenicity and tolerability of a paediatric presentation of a virosomal hepatitis A vaccine in Chilean children aged 1–16 years

Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India

“…23 Overall, the GMCs observed in the present study were similar for both groups at Month 1 and numerically lower in the HAVpur Junior group than in the Havrix 720 Junior group at Month 7. A similar pattern was observed in the studies in Chile and Belgium 21,22 while in the study in Israel consistently higher GMC values were detected with the pediatric dose of the virosomal HAV vaccine than with Havrix 720 Junior throughout the study. 23 However, the small differences in HAV GMCs seen in the present study are not considered clinically relevant as the Figure 2.…”

“…Furthermore, Epaxal Junior had a better tolerability profile regarding local injection site reactions than Havrix 720 Junior. A third study conducted in Chile in 360 children aged 1 to 16 y produced similar results to the Belgian study: 22 the pediatric dose of the virosomal HAV vaccine elicited seroprotection rates comparable to those seen after immunization with the standard dose or with Havrix 720 Junior. The vaccines were well tolerated with relatively low incidences of adverse events.…”

“…In a further study with 322 children in Israel, a co-administration of the pediatric virosomal HAV vaccine (Epaxal Junior) with routine childhood vaccines showed immunogenicity and safety equal to Epaxal Junior administered alone and with Havrix 720 Junior co-administered with routine childhood vaccines. 23 The present study was designed to confirm the results obtained in the earlier trials [20][21][22][23] and to increase the amount of clinical information available regarding safety and immunogenicity of the pediatric dose of the virosomal HAV vaccine.…”

“…Two of the studies were conducted in children aged 1 to 16 y, with the majority being older than 4 y. 21,22 The third study assessed the co-administration of hepatitis A and routine childhood vaccines in children aged 12 to 15 mo. 23 In all three studies the immunogenicity of the pediatric dose was similar to the standard dose and Havrix 720 Junior.…”

“…Overall, the immunogenicity results in both groups were similar to those observed in the previous randomized studies comparing the pediatric dose of the virosomal HAV vaccine and Havrix 720 Junior. [21][22][23] The GMCs of anti-HAV antibodies increased from around 50 mIU/mL at Month 1 to around 100 mIU/mL at Month 6 (before second vaccination) and to around 2000 mIU/mL at Month 7 (1 mo after second vaccination). This increase in GMC from Month 1 to Month 6, observed in both groups in the present study, is unusual and may be explained by natural exposure to HAV in the HAV-endemic study area.…”