Delving into the Latest Updates on Hib-DTP-hepatitis B vaccine(PT Bio Farma) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Toxoid vaccine

Synonyms

Hib-DTP-hepatitis B vaccine, Pentabio vaccine

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System DisordersRespiratory Diseases+ [1]

Active Indication

DiphtheriaHaemophilus InfectionsHepatitis B+ [2]

Inactive Indication-

Originator Organization

PT Bio Farma

Active Organization

PT Bio Farma

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (01 Dec 2013),

DiphtheriaHaemophilus InfectionsHepatitis B+ [2]

Regulation-

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This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.

Start Date01 Mar 2025

Sponsor / Collaborator

PT Bio Farma

[+1]

NCT04071379 / CompletedPhase 3

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose (Using Different Source of Hepatitis B), in Indonesian Infants

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

Start Date13 Oct 2020

Sponsor / Collaborator

PT Bio Farma

NCT03310073 / CompletedPhase 4

Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants

This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit

Start Date01 Jul 2016

Sponsor / Collaborator

PT Bio Farma

100 Clinical Results associated with Hib-DTP-hepatitis B vaccine(PT Bio Farma)

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100 Translational Medicine associated with Hib-DTP-hepatitis B vaccine(PT Bio Farma)

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100 Patents (Medical) associated with Hib-DTP-hepatitis B vaccine(PT Bio Farma)

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5

Literatures (Medical) associated with Hib-DTP-hepatitis B vaccine(PT Bio Farma)

01 Dec 2021·Indian PediatricsQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: Rajabnejad, Maryam ; Shamshiri, Ahmadreza ; Azimi, Leila ; Faghihian, Eiman ; Mohammadi, Sousan ; Tabatabaei, Sedigheh Rafiei ; Karimi, Abdollah ; Zahraei, Seyed Mohsen ; Faghihian, Reyhaneh ; Esteghamati, Abdoulreza ; Shirvani, Fariba

BACKGROUNDThe pentavalent vaccine Pentavac was officially introduced in the Iranian National Immunization Plan in November, 2014.OBJECTIVETo compare the immunogenicity and safety of Pentavac vaccine (Serum Institute of India Ltd.) with two other pentavalent vaccines available in Iran, i.e., Pentabio (PT Bio Farma (Persero)) and Shan 5 (Shantha Biotechnics Ltd.).DESIGNRandomized, phase III study.PARTICIPANTS900 infants attending the study sites to receive the vaccine at 2, 4, and 6 months of age.INTERVENTIONInfants were randomly assigned to one of the Pentavac, Pentabio, and Shan 5 vaccine groups.OUTCOMESThe antibody titers were measured against five antigens, diphtheria, tetanus, pertussis, Haemophilus influenzae B, and hepatitis B before receiving the first dose and one month after the last dose. The adverse events following vaccination after each dose were recorded in the adverse events diary.RESULTSAll vaccines showed similar immunogenicity against four of the five antigens except pertussis. While vaccination with Shan 5 resulted in the highest immunogenicity against pertussis, Pentabio was significantly lower than the other two vaccines (P<0.001). The incidence of local adverse events significantly differed among the three vaccine brands (P<0.001), but the incidence of most of the evaluated systemic adverse events was similar (P>0.05).CONCLUSIONSPentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile.

01 Feb 2020·VaccineQ3 · MEDICINE

Immunogenicity and safety profile of a primary dose of bivalent oral polio vaccine given simultaneously with DTwP-Hb-Hib and inactivated poliovirus vaccine at the 4th visit in Indonesian infants

Q3 · MEDICINE

Article

Author: Rusmil, Kusnandi ; Dhamayanti, Meita ; Mulia Sari, Rini ; Kartasasmita, Cissy B ; Sjafri Bachtiar, Novilia ; Fadlyana, Eddy ; Tarigan, Rodman

In this study, we aimed to evaluate the immunological protectivity of infants following four doses of bivalent oral polio vaccine (bOPV; Bio Farma), which were given simultaneously with DTwP-Hb-Hib (Pentabio®), along with one dose of inactivated poliovirus vaccine (IPV) at the fourth visit. A total of 143 newborn infants who fulfilled the inclusion criteria were enrolled and completed the study. Subjects received the first dose of bOPV at birth. On days 60, 90 and 120, bOPV was given simultaneously with Pentabio®. On day 120, one dose of IPV was also administered. Serum samples for serology analysis were collected before the first dose of bOPV (at day 0), before the second dose of bOPV (at day 60) and 30 days after the last dose of bOPV. In addition, the intensity, duration and relationship of each adverse event to the trial vaccines were assessed. Seroprotection rates after the fourth dose of bOPV were 100%, 91.6% and 99.3% for poliovirus P1, P2 and P3, respectively. Seroconversion rates after the fourth dose of bOPV were 100.0%, 93.3% and 100% for poliovirus P1, P2 and P3, respectively. There were no severe adverse events, and systemic reactions were generally mild during the 1-28 day post-vaccination period. Collectively, our findings indicate that bOPV given simultaneously with Pentabio® and one dose of IPV at the 4th visit was immunogenic and well tolerated.

01 Dec 2018·BMC PediatricsQ4 · MEDICINE

DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old

Q4 · MEDICINE

ArticleOA

Author: Tarigan, Rodman ; Soedjatmiko ; Kartasasmita, Cissy B ; Fadlyana, Eddy ; Medise, Bernie Endyarni ; Sekartini, Rini ; Rusmil, Kusnandi ; Gunardi, Hartono ; Bachtiar, Novilia Sjafri ; Sari, Rini Mulia ; Satari, Hindra Irawan ; Dhamayanti, Meita ; Hadinegoro, Sri Rezeki S

BACKGROUNDThe new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib.METHODSThis was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards.RESULTSThere were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P < 0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period.CONCLUSIONSBooster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination.TRIAL REGISTRATIONNCT02095314 (retrospectively registered, March 24, 2014).

100 Deals associated with Hib-DTP-hepatitis B vaccine(PT Bio Farma)

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External Link

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-	Hib-DTP-hepatitis B vaccine(PT Bio Farma)	J07CA11	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	IN	PT Bio Farma	01 Dec 2013
Haemophilus Infections	IN	PT Bio Farma	01 Dec 2013
Hepatitis B	IN	PT Bio Farma	01 Dec 2013
Tetanus	IN	PT Bio Farma	01 Dec 2013
Whooping Cough	IN	PT Bio Farma	01 Dec 2013