Clinical trial NCT05482295: Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Vaccine Reaction
Vaccine Adverse Reaction
Keywords: Hepatitis B vaccine, Vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: RS Prof. Dr. I.G.N.G Ngoerah
First posted: 2022-08-01
Enrollment: 540
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, randomized, observer-blind, lot to lot consistency
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
3. Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years.
3. Evolving severe illness and/or chronic disease and fever (axillary temperature \>= 37.5 C) within the 48 hours preceding enrollment.
4. Known history of allergy to any component of the vaccines (based on anamnesis).
5. HBsAg positive.
6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
8. 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.
9. Pregnancy \& Lactation (Adult).
10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.

Primary outcomes:
measure: Protectivity
timeFrame: 28 days after the primary series of Hepatitis B vaccination
Secondary outcomes:
measure: Immunogenicity: Serological response
timeFrame: 28 days after the primary series of Hepatitis B vaccination
measure: Immunogenicity: comparison between IP & control
timeFrame: 28 days after the primary series of Hepatitis B vaccination
measure: Immunogenicity: comparison among each batch of IP
timeFrame: 28 days after the primary series of Hepatitis B vaccination
measure: Safety: Immediate reaction, Local and systemic events
timeFrame: within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection
measure: Safety: Serious adverse event
timeFrame: from inclusion until 28 days after the last injection
measure: Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control
timeFrame: 28 days after each dose
measure: Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B
timeFrame: 28 days after each dose
Other outcomes:
Locations:
Study officials:
affiliation: RSUP Prof. dr. I.G.N.G. Ngoerah
name: Trisna Windiani, MD
role: PRINCIPAL_INVESTIGATOR
References: