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Not yet recruiting NCT05482295

Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

Phase III Interventional Vaccine Reaction Vaccine Adverse Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B).
Who it may be relevant to
Registry conditions: Vaccine Reaction, Vaccine Adverse Reaction. Basic parameters: 10 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)

Overview

This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

Detailed description

This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this study.

The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

Interventions

  • Biological In-House Recombinant Hepatitis B (Bio Farma) vaccine
    3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine
  • Biological Registered Hepatitis B vaccine recombinant (Engerix-B)
    3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)

Primary outcome measures

  • Protectivity [Time frame: 28 days after the primary series of Hepatitis B vaccination]
Secondary outcome measures (7)
  • Immunogenicity: Serological response [Time frame: 28 days after the primary series of Hepatitis B vaccination]
  • Immunogenicity: comparison between IP & control [Time frame: 28 days after the primary series of Hepatitis B vaccination]
  • Immunogenicity: comparison among each batch of IP [Time frame: 28 days after the primary series of Hepatitis B vaccination]
  • Safety: Immediate reaction, Local and systemic events [Time frame: within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection]
  • Safety: Serious adverse event [Time frame: from inclusion until 28 days after the last injection]
  • Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control [Time frame: 28 days after each dose]
  • Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B [Time frame: 28 days after each dose]

Eligibility criteria

Inclusion criteria

  • Healthy individual aged 10 - 50 years old, as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.
  • Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
  • Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion criteria

  • Subject concomitantly enrolled or scheduled to be enrolled in another trial.
  • Subjects with known history of Hepatitis B contained vaccination in the last 10 years.
  • Evolving severe illness and/or chronic disease and fever (axillary temperature >= 37.5 C) within the 48 hours preceding enrollment.
  • Known history of allergy to any component of the vaccines (based on anamnesis).
  • HBsAg positive.
  • Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
  • History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
  • Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppressant.
  • Pregnancy \& Lactation (Adult).
  • Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05482295 · HepB 0322

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗