Study Interchangeability Hep-B Vaccine Administered at Birth Dose

NCT07854847 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HepB0226
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.

Conditions

Vaccination Adverse Event; Immunogenicity, Vaccine

Keywords

Vaccine; Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Protectivity of primary series In-House Recombinant Hepatitis B vaccine

  Percentage of subjects with anti HBsAg \> 10mIU/ml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group

  28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine

Secondary Outcomes (4)

• Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine

  28 days after administration of Hep B birth dose vaccine

• Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine

  28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine

• Safety of In-House Recombinant Hepatitis B vaccine

  30 minutes, 7 days, 28 days after each dose

• Serious Adverse Events

  28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration

Study Arms (2)

Hep B vaccine in-house

EXPERIMENTAL

0,5 ml of In-house Recombinant Hepatitis B (Bio Farma) vaccine injected at birth

Biological: In-house Hepatitis B Vaccine

Registered Hep B vaccine

ACTIVE COMPARATOR

0,5 ml of Regstered Hepatitis B (Bio Farma) vaccine injected at birth

Biological: Registered Hepatitis B Vaccine

Interventions

In-house Hepatitis B Vaccine BIOLOGICAL

0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh

Hep B vaccine in-house

Registered Hepatitis B Vaccine BIOLOGICAL

0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh

Registered Hep B vaccine

Eligibility Criteria

• Age: 0 Days - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy, full term, newborn infants.
• Infant born between 37-42 weeks of pregnancy.
• Infant weigh between 2500 - 4000 gram at birth.
• Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
• Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.

You may not qualify if:

• Infants concomitantly enrolled or scheduled to be enrolled in another trial.
• Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).
• Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.
• Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
• Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.
• Infants with HbsAg and HIV positive (from cord blood)
• Mother suspected of immunodeficiency disease based on anamnesis

Sponsors & Collaborators

• PT Bio Farma: lead
• Faculty of Medicine Universitas Padjadjaran: collaborator

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Rodman Tarigan Girsang, MD

  Faculty of Medicine, Padjadjaran University, Bandung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rini Mulia Sari, MD

CONTACT

+622033755; rini.mulia@biofarma.co.id

Mita Puspita, MD

CONTACT

+622033755; mita.puspita@biofarma.co.id

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Inclusion number will be allocated in the chronological order of the subject inclusion in the trial. The subject will be randomized by treatment group. The randomization list will be provided by unblinded personnel of the study team. The unblinded team will keep the list until Sponsor formally issues the result of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, two arms parallel groups, prospective intervention study.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share