Study title: A study to assess the immunogenicity and reactogenicity of a Hepatitis A vaccine administered subcutaneously to patients with congenital coagulation disorders using a single primary dose and a booster dose at 6 months at a dose of 1440 ElU (in 1 ml) to adults and 720 ElU (in 0.5ml) in children.
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 | |||||
Assessment: | |||||
Active substance: Inactivated hepatitis A virus | |||||
ATC code: J07BC02 | |||||
Document link: | |||||
Document date: 2011-09-23 | |||||
Study number: 208109/145 | |||||
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) |
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