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,
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,050
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Covovax
Bali Mandara Hospital
Denpasar, Bali, Indonesia
Universitas Udayana Hospital
Denpasar, Bali, Indonesia
RSUD Hj. Anna Lasmanah
Banjarnegara, Central Java, Indonesia
Abdoel Moeloek Hospital
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
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Bandar Lampung, Lampung, Indonesia
Rumpin Primary Health Care
Bogor, West Java, Indonesia
Duren Seribu Primary Health Care
Depok, West Java, Indonesia
Pasir Putih Primary Health Care
Depok, West Java, Indonesia
Universitas Mataram Hospital
Mataram, West Nusa Tenggara, Indonesia
M Djamil Hospital
Padang, West Sumatra, Indonesia
RS Universitas Andalas
Padang, West Sumatra, Indonesia
SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody
Time frame: 3, 6 and 12 months after primary series