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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2015

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

    • 12 Dec 2015 Status changed from recruiting to completed as per European Clinical Trials Database record.
    • 15 Sep 2014 New trial record
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top