Study title: A phase II, double blind, randomized, double center, controlled study to evaluate the safety and immunogenicity of four formulations of DTwPHib combined vaccine containing different concentrations of Hib conjugate in healthy infants at 3, 4, 5 months of age.Please see report- sturdy report
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Bacterial Infections and Mycoses | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) | |||||
ATC code: J07AJ01 | |||||
Document link: V45P1.xlsx | |||||
Document date: 2015-02-26 | |||||
Study number: V45P1 | |||||
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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