Study title: Phase III trial on the persistence of antibodies 5 years after a primo-vaccination and 4 years after a first booster with PENTAVAC® vaccine and the immunogenicity and safery of a second booster with TETRAVAC-ACELLULAIRE® vaccine at the ager of 5-6 years
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Virus Diseases [C02] | |||||
Brands: Please see report, Please see report, Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) | |||||
ATC code: J07BF03 | |||||
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Document date: | |||||
Study number: F99-2I-015 | |||||
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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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