Study title: An open label, not randomized, age stratified trial to study safety and efficacy of the vaccine in subjects from 6 to 35 months of age.Please see report - study 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: MEMUFL-95-001.xlsx | |||||
Document date: 2015-02-26 | |||||
Study number: MEMUFL-95-001 | |||||
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 | Y | - |