Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11 to...

Update Il y a 5 ans
Reference: U1111-1122-2235

Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11 to 12 Months of Age in Healthy Infants in Europe

Woman and Man

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Extract

To demonstrate the non-inferiority of the Hexaxim vaccine to the licensed Infanrix hexa vaccine, both co-administered with Prevenar 13, in terms of seroprotection or vaccine response rates to all antigens contained in both investigational and control vaccines, 1 month after a 2+1-dose schedule.


Inclusion criteria

  • 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