Booster Effect and Safety of a DTaP-IPV-Hib Combined Vaccine, with or without Hep B, in Healthy Subjects 11 to 18 Months of Age Who Received a Hexavalent or Hexavalent/Pentavalent Combined Vaccine dur...

Mise à jour : Il y a 4 ans
Référence : U1111-1122-2362

Booster Effect and Safety of a DTaP-IPV-Hib Combined Vaccine, with or without Hep B, in Healthy Subjects 11 to 18 Months of Age Who Received a Hexavalent or Hexavalent/Pentavalent Combined Vaccine during the Primary Series Účinek a bezpečnost přeočkování kombinovanou vakcínou DTaP-IPV-Hib s podáním vakcíny proti hepatitidě B či bez ní u zdravých subjektů ve věku 11 až 18 měsíců, kteří během primární série obdržely hexavalentní nebo hexavalentní/pentavalentní kombinovanou vakcínu

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Extrait

Immunogenicity Groups 1 and 2 • Assess the antibody persistence of DTaP-IPV-HB-Hib or Infanrix hexa following a 3-dose primary series at 2, 3, and 4 months of age (MoA) before the administration of a booster dose of either vaccine • Describe the immunogenicity and booster effect of the DTaP-IPV-HB-Hib or Infanrix hexa vaccine given as a booster dose at 11 to 15 MoA concomitantly with PCV13 (after a primary series with the same vaccine) • To describe the immunogenicity of a booster dose of PCV13 given from 11 to 15 MoA Group 3 • Assess the antibody persistence of all valences contained in the vaccines administered in a mixed schedule following a 3-dose primary series at 2, 4, and 6 MoA before the administration of a booster dose of Pentavac • Describe the immunogenicity and booster effect of Pentavac given at 18 MoA after the administration of a mixed schedule primary series combining a hexavalent and a pentavalent vaccine To describe the safety profile for groups 1, 2 and 3


Critère d'inclusion

  • Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus