Study title: Immunogenicity and protective efficacy of Smith Kline -RIT's rec-DNA hepatitis b vaccine (10mcg) in newborns of HBsAg positive or negative mothers.
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Virus Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: r-DNA hepatitis B surface antigen (HBsAg) | |||||
ATC code: J07BC01 | |||||
Document link: | |||||
Document date: 2011-11-10 | |||||
Study number: 103860-034 (HBV-154) and 103860-023 (HBV-155) | |||||
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 | - | - | - |