Trial intelligence / Profile preview

Phase 3 study of Shan6 versus Shan5 with bOPV and IPV in healthy Kenyan infants

2022-003923-17Phase 3

Sponsor
Sanofi
Start
Jan 2023
Modality
Vaccines & Immunotherapeutics, Live Attenuated Vaccines → Live Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 3 trial of DTwP-HepB-Hib-IPV hexavalent vaccine, DTwP-HepB-Hib vaccine, bivalent oral poliovirus vaccine and inactivated poliovirus vaccine in pertussis, diphtheria, Tetanus and 3 more (3 arms), sponsored by Sanofi. Primary endpoints: Antibody response above predefined thresholds for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, and poliovirus antigens and Non-inferiority of Shan6 versus control for pertussis and other vaccine antigens.

02

Drugs

DTwP-HepB-Hib-IPV hexavalent vaccineDTwP-HepB-Hib vaccinebivalent oral poliovirus vaccineinactivated poliovirus vaccine
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Conditions

pertussisdiphtheriaTetanushepatitis B (HBV)Haemophilus influenzae type b disease (Hib)

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