Study title: A phase III, open-label, multi-centre study to evaluate the safety, tolerability and immunogenicity of CSL´s influenza vaccine in two paediatric populations, Group A (≥ 6 month to ≥ 3 years) and Group B (≥ 3 years to < 9 years).
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Virus Diseases | |||||
Brands: Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: Influenza Vaccine (Split Virion, Inactivated) | |||||
ATC code: | |||||
Document link: | |||||
Document date: 2011-09-15 | |||||
Study number: Afluria-repeat-Synposis of CSLCT-FLU-04-05 | |||||
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Scope of study: | |||||
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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