Trial intelligence / Profile preview

Safety and Immunogenicity of DTwP-Hepatitis B-Hib-IPV Vaccine in Indonesian Infants

NCT06690515Phase 2Not yet recruiting

Sponsor
Bio Farma
Start
Mar 2025
Primary completion
Oct 2025
Modality
Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 2, randomised, open-label trial of diphtheria + tetanus + whole-cell pertussis + hepatitis B + haemophilus influenzae type b + inactivated poliovirus in diphtheria, Tetanus, pertussis and 3 more (3 arms), sponsored by Bio Farma. Primary endpoints: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose and Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine. Planned start Mar 2025; status: not yet recruiting.

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Drugs

diphtheria + tetanus + whole-cell pertussis + hepatitis B + haemophilus influenzae type b + inactivated poliovirus
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Conditions

diphtheriaTetanuspertussishepatitis B (HBV)Haemophilus influenzae type b infection (Hib)

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