Trial intelligence / Profile preview

Infanrix-IPV/Hib Immunogenicity and Safety in Healthy Indian Infants

NCT03128489Phase 3Withdrawn

Sponsor
GSK
Start
Dec 2017
Primary completion
Aug 2018
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
01

Overview

Phase 3, open-label, single-arm trial of diphtheria + tetanus + acellular pertussis + inactivated poliomyelitis + Haemophilus influenzae type b vaccine in diphtheria, Tetanus, pertussis and 2 more, sponsored by GSK. Primary endpoints: Number of seroprotected subjects in terms of anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies at Month 3, Number of seroprotected subjects in terms of anti-poliomyelitis (anti-Polio) types 1, 2 and 3 antibodies at Month 3 and 2 more. Planned start Dec 2017; status: withdrawn.

02

Drugs

diphtheria + tetanus + acellular pertussis + inactivated poliomyelitis + Haemophilus influenzae type b vaccine
03

Conditions

diphtheriaTetanuspertussispoliomyelitisHaemophilus influenzae type b infection (Hib)

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