Study title: Phase III, controlled, open-label, randomized, single-center study to evaluate the safety and immunogenicity using four different vaccination schedules of tick-borne encephalitis (TBE) - polygeline free vaccine in adolescents and adults.
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Virus Diseases [C02] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: Tick-Borne Encephalitis Virus | |||||
ATC code: J07BA01 | |||||
Document link: | |||||
Document date: 2014-10-14 | |||||
Study number: V48P7 | |||||
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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