Clinical trial NCT03919578: Protectivity and Safety Following Recombinant Hepatitis B Vaccine
Official title: Protectivity and Safety Following Recombinant Hepatitis B Vaccine With Different Source of Hepatitis B Bulk Compared to Hepatitis B (Bio Farma) Vaccine in Indonesian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Immunogenicity
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 536
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, randomized, double blind, four arm parallel group study
Primary purpose: PREVENTION

Brief summary: Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population

Detailed description: Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.

Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.

Eligibility criteria: Inclusion Criteria:

1. Healthy individu 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 more than37.5oC) 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 immunosuppresant.
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: Percentage of subjects with increasing antibody titer >= 4 times
timeFrame: 28 days after the last dose immunization
Secondary outcomes:
measure: Geometric Mean Titer (GMT)
timeFrame: 28 days after the last dose immunization
measure: Percentage of subjects with transition of seronegative to seropositive
timeFrame: 28 days after the last dose immunization
measure: Percentage of subjects with at least one immediate reaction
timeFrame: 30 minutes after each vaccination
measure: Percentage of subjects with at least one of these adverse events
timeFrame: within 72 hours, between 72 hours to 28 days after vaccination
measure: Serious adverse event after vaccination
timeFrame: 28 days after the last dose immunization
measure: Comparison adverse events between Investigational Products (Hepatitis B) and Control
timeFrame: 28 days after each dose
measure: Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine
timeFrame: 28 days after each dose
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: RSND
state: Central Java
Study officials:
affiliation: Universitas Diponegoro
name: Yetty M Nency, MD
role: PRINCIPAL_INVESTIGATOR
References: