Study title: Open randomised controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 mL) and the standard dose (0.5 mL) of Epaxal® with reference to Havrix Juniror® in healthy children and adolescents (³ 1-16 years) using a 0/6 month schedule.
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Virus Diseases [C02] | |||||
Brands: Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: Inactivated hepatitis A virus (strain RG-SB). | |||||
ATC code: J07BC02 | |||||
Document link: | |||||
Document date: | |||||
Study number: EPA 001-T | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | Y | Y | Y |