Trial intelligence / Profile preview

Pentaxim primary infant vaccination schedules versus separate DTaP, Hib, and IPV vaccines in China

2015-005353-12Phase 3

Sponsor
Sanofi
Start
Dec 2015
Modality
Vaccines & Immunotherapeutics
Countries
1
01

Overview

Phase 3 trial of diphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccine, Haemophilus influenzae type B strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen, inactivated poliovirus vaccine and diphtheria, tetanus, and acellular pertussis vaccine in Haemophilus influenzae type b disease (Hib), poliomyelitis, diphtheria and 2 more (3 arms), sponsored by Sanofi. Primary endpoints: Seroprotection non-inferiority after primary vaccination, Pertussis immune response non-inferiority after primary vaccination and 1 more.

02

Drugs

diphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccineHaemophilus influenzae type B strain 1482 capsular polysaccharide tetanus toxoid conjugate antigeninactivated poliovirus vaccinediphtheria, tetanus, and acellular pertussis vaccine
03

Conditions

Haemophilus influenzae type b disease (Hib)poliomyelitisdiphtheriaTetanuspertussis

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