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This Phase III multi-center study of DTaP-IPV-Hib, with or without Hep B, used as a booster vaccine in healthy infants and toddlers will be conducted with two controlled, blind-observer trial arms in Germany and the Czech Republic and an open-label trial arm in Spain. Subjects in Germany and the Czech Republic will receive (at 11 to 15 months of age) a booster dose of the same DTaP-IPV-HB-Hib investigational vaccine or the Infanrix hexa control vaccine they received during the primary series in Study A3L39 concomitantly with a booster dose of Prevenar 13. All subjects in Spain received 2 doses of the DTaP-IPV-HB-Hib investigational vaccine and a dose of Pentavac (DTaP-IPV//Hib) in the primary series, and will receive (at 18 months of age) a booster dose of Pentavac concomitantly with a booster dose of Prevenar 13.

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Trial Profile

This Phase III multi-center study of DTaP-IPV-Hib, with or without Hep B, used as a booster vaccine in healthy infants and toddlers will be conducted with two controlled, blind-observer trial arms in Germany and the Czech Republic and an open-label trial arm in Spain. Subjects in Germany and the Czech Republic will receive (at 11 to 15 months of age) a booster dose of the same DTaP-IPV-HB-Hib investigational vaccine or the Infanrix hexa control vaccine they received during the primary series in Study A3L39 concomitantly with a booster dose of Prevenar 13. All subjects in Spain received 2 doses of the DTaP-IPV-HB-Hib investigational vaccine and a dose of Pentavac (DTaP-IPV//Hib) in the primary series, and will receive (at 18 months of age) a booster dose of Pentavac concomitantly with a booster dose of Prevenar 13.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2018

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At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Hib-DTP-hepatitis B vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Sanofi Pasteur

    • Most Recent Events

    • 07 Nov 2018 Results from U1111-1122-2329 and U1111-1122-2362 studies published in the Pediatric Infectious Disease Journal
    • 14 May 2018 Results from U1111-1122-2329 and U1111-1122-2362 studies published in the Pediatric Infectious Disease Journal.
    • 12 Dec 2015 Status changed from recruiting to completed as per European Clinical Trials Database record.
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