A Phase 3 interventional study of SARS-CoV-2 Protein Subunit Recombinant Vaccine and Active Comparator in Vaccine Reaction and Vaccine Adverse Reaction, sponsored by PT Bio Farma. Completed at 10 sites in Indonesia. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by PT Bio Farma · Phase 3, Interventional, and Prevention
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial.
The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study.
Main Study for immunogenicity and safety evaluation.
Exploratory Study for cellular immunity evaluation,
PT Bio Farma is the lead sponsor of 44 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)
Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose)
Biological: Active Comparator
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Covovax
To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series
Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2, measured by neutralization assay (against omicron variant) at 14 days after primary series
Time frame: 14 days after primary series
To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine.
Seroconversion rate and Seropositive rate of neutralizing antibody at baseline and 14 days after primary series vaccination.
Time frame: 14 days after primary series
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
Local reactions and systemic events
Time frame: 28 days after each dose
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
Serious Adverse Event
Time frame: 12 months after primary series
To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.
local reactions, systemic events
Time frame: 28 days after each dose
To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.
SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody
Time frame: 28 days after each dose
To evaluate antibody persistence 3, 6 and 12 months after primary series
SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody
Time frame: 3, 6 and 12 months after primary series
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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PT Bio Farma