Study title: A phase II, open-label, single-centre, singal-arm, extension study to evaluate the safety and immunogenicity of a booster vaccination of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) administered to 18-20 months old healthy infants who had previously received either DTPHib combined vaccine or separate administrations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines at 2, 3 and 4 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: V38P1E1.xlsx | |||||
Document date: 2015-02-26 | |||||
Study number: V38P1E1 | |||||
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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