Study title: Open, controlled randomised multi-centre study to assess and compare local reactions of a single dose of Epaxal® to Havrix Monodose® and Havrix Junior® (where applicable) in parallel-groups.
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 005 | |||||
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) |
- | - | - | - | - |