Pentabio (diphtheria-tetanus-pertussis (whole cell)-hepatitis B- haemophilus influenzae type b) / Bio Farma Indonesia - LARVOL DELTA

Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: PT Bio Farma | N=220 ➔ 0 | Trial completion date: Jul 2025 ➔ Dec 2026 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Apr 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Hepatitis B • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Immunogenicity, reactogenicity, and IgE-mediated immune responses of a mixed whole-cell and acellular pertussis vaccine schedule in Australian infants: A randomised, double-blind, noninferiority trial. (PubMed, PLoS Med) - "In stage one, infants were assigned (1:1) to either a first dose of a pentavalent wP combination vaccine (DTwP-Hib-HepB, Pentabio PT Bio Farma, Indonesia) or a hexavalent aP vaccine (DTaP-Hib-HepB-IPV, Infanrix hexa, GlaxoSmithKline, Australia) at approximately 6 weeks old. Subsequently, all infants received the hexavalent aP vaccine at 4 and 6 months old as well as an aP vaccine at 18 months old (DTaP-IPV, Infanrix-IPV, GlaxoSmithKline, Australia)...https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371998&isReview=true. Just one registry (as above)."

Head-to-Head • Journal • Allergy • Food Hypersensitivity • Immunology • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: PT Bio Farma | Trial completion date: Feb 2023 ➔ Jul 2025 | Trial primary completion date: Dec 2022 ➔ Apr 2025

Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Comparison of Immunogenicity and Safety of Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenza B (Bio Farma) with Pentabio Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants. (PubMed, Vaccines (Basel)) - "No serious adverse events related to the study vaccine occurred. The three-dose DTP-HB-Hib vaccine (Bio Farma) is immunogenic, well tolerated, and suitable to replace licensed-equivalent vaccines."

Clinical • Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: PT Bio Farma

New P3 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pertussis • Respiratory Diseases • Tetanus

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B (clinicaltrials.gov) - P3; N=220; Completed; Sponsor: PT Bio Farma; Active, not recruiting ➔ Completed

Clinical • Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Immunogenicity and Safety of Three WHO Prequalified (DTwP -HB-Hib) Pentavalent Combination Vaccines Administered As Per Iranian National Immunization Plan in Iranian Infants: A Randomized, Phase III Study. (PubMed, Indian Pediatr) - "Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile."

Clinical • Journal • P3 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pertussis • Respiratory Diseases • Tetanus

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B (clinicaltrials.gov) - P3; N=220; Active, not recruiting; Sponsor: PT Bio Farma; Recruiting ➔ Active, not recruiting; Trial completion date: Mar 2021 ➔ Nov 2021

Clinical • Enrollment closed • Trial completion date • Hepatitis B • Hepatology • Infectious Disease

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B (clinicaltrials.gov) - P3; N=220; Recruiting; Sponsor: PT Bio Farma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatitis B • Hepatology • Infectious Disease