Safety and Immunogenicity of Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Children

Update Il y a 4 ans
Reference: EUCTR2005-003508-12

Woman and Man

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Extract

Main objective : (1) To evaluate the immunogenicity of intramuscular INFANRIX™ hexa (in relation to serum anti-polyribosylribitol phosphate [PRP] and anti-hepatitis B surface antigen [HBsAg]) when administered concomitantly with RotaTeq™†; (2) To assess the safety of RotaTeq™ when administered concomitantly with intramuscular INFANRIX™ hexa.


Inclusion criteria

  • RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1 (e.g., G9)