Concomitant administration of a virosome-adjuvanted hepatitis a vaccine with routine childhood vaccines at age twelve to fifteen months: a randomized controlled trial.

摘要: BACKGROUND: The objectives of this trial were to test for noninferiority a virosomal hepatitis A virus (HAV) vaccine (Epaxal) coadministered with routine childhood vaccines compared Epaxal given alone and an alum-adjuvanted HAV (Havrix Junior) vaccines. METHODS: Healthy children 12- 15-month-old randomized receive either pediatric dose (0.25 mL) DTPaHibIPV, oral polio vaccine, measles-mumps-rubella (n = 109; group A), or 105; B), Havrix Junior 108; C). booster was 6 months later. Anti-HAV antibodies tested before 1 month after each vaccination. Safety assessed Solicited adverse events 4 days RESULTS:: seroprotection rates (> =20 mIU/mL) at first were: A: 94.2% 87.5%, B: 92.6% 80.0%, C: 78.2% 71.3%, respectively (A versus P< 0.001 P 0.017 6, respectively). respective geometric mean concentrations 51 64 mIU/mL, 49 59 33 37 mIU/mL both time points). All groups achieved 100% the dose. 1758, 1662, 1414, A, B C, 0.15). No clinically significant reduction in immune response all concomitant antigens seen. well tolerated. CONCLUSIONS:: Coadministration showed immunogenicity safety equal as Junior. After dose, significantly more immunogenic than