Vaccine ReactionPhase 3NCT05546502
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
A Phase 3 study testing SARS-CoV-2 Protein Subunit Recombinant Vaccine and Active Comparator in people with Vaccine Reaction and Vaccine Adverse Reaction, run by PT Bio Farma at 10 sites in Indonesia.
Trial summary
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction, Vaccine Adverse Reaction
- What is being tested?
- SARS-CoV-2 Protein Subunit Recombinant Vaccine and Active Comparator
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 10 sitesIndonesia
- Study dates
- 9 Oct 2022to 31 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinically healthy children aged 12-17 years.
- Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years).
- Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- History of vaccination with any COVID-19 vaccine (based on anamnesis).
- Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
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- Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
- Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
- Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
- Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- 11. Subjects plan to move from the study area before the end of study period.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Indonesia10 sites
Abdoel Moeloek Hospital
Bandar Lampung, Lampung
RSUD Hj. Anna Lasmanah
Banjarnegara, Central Java
Rumpin Primary Health Care
Bogor, West Java
Bali Mandara Hospital
Denpasar, Bali
Universitas Udayana Hospital
Denpasar, Bali
Duren Seribu Primary Health Care
Depok, West Java
Pasir Putih Primary Health Care
Depok, West Java
Universitas Mataram Hospital
Mataram, West Nusa Tenggara
M Djamil Hospital
Padang, West Sumatra
RS Universitas Andalas
Padang, West Sumatra
About this study
Official title: A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
Read the detailed description
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,
- Conditions
- Vaccine Reaction, Vaccine Adverse Reaction
- Being tested
- SARS-CoV-2 Protein Subunit Recombinant Vaccine, Active Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Protein Subunit Recombinant VaccineBiological
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Active ComparatorBiological
Covovax
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Protein Subunit Recombinant Vaccine | Experimental | 2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose) Receives: Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine |
| Active Comparator | Active comparator | 2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose) Receives: Biological: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days after primary series
Secondary outcomes (6)
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.
Measured: 14 days after primary series
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
Local reactions and systemic events
Measured: 28 days after each dose
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
Serious Adverse Event
Measured: 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
Measured: 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
Measured: 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
Measured: 3, 6 and 12 months after primary series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start9 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Vaccine candidate and active comparator are masking
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM, Dr Cipto Mangunkusumo General Hospital, Andalas University
- Responsible party
- Sponsor
- Investigators
- Cahya Satria, MD, Principal investigator, CC PRO UGMBernie Medise, MD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaAsrawati Asrawati, MD, Principal investigator, Andalas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546502
- Sponsor's protocol ID
- CoV2-Children-0322
- Status last verified
- Jun 2025
- First submitted
- 4 Sep 2022
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia
- ClinicalTrials.gov ID
- NCT05546502
- Acronym / sponsor ID
- CoV2-Children-0322
- Conditions
- Vaccine Reaction, Vaccine Adverse Reaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM, Dr Cipto Mangunkusumo General Hospital, Andalas University
- Study start
- 9 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Vaccine candidate and active comparator are masking
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Protein Subunit Recombinant Vaccine | Experimental | Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose) |
| Active Comparator | Active comparator | Biological: Active Comparator2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinically healthy children aged 12-17 years.
- Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years).
- Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.
Key exclusion criteria (12 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- History of vaccination with any COVID-19 vaccine (based on anamnesis).
- Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 Protein Subunit Recombinant VaccineSARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma | Biological | COVID-19 Protein Subunit Recombinant Vaccine |
| Active ComparatorCovovax | Biological | Active Comparator |
Primary outcome
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
Time frame: 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
6 secondary outcomes
To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine.
Time frame: 14 days after primary series
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
Time frame: 28 days after each dose
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
Time frame: 12 months after primary series
To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.
Time frame: 28 days after each dose
To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.
Time frame: 28 days after each dose
To evaluate antibody persistence 3, 6 and 12 months after primary series
Time frame: 3, 6 and 12 months after primary series
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cahya Satria, MD principal investigator
CC PRO UGM
Bernie Medise, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
Asrawati Asrawati, MD principal investigator
Andalas University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SARS-CoV-2 Protein Subunit Recombinant Vaccine and Active Comparator in people with Vaccine Reaction and Vaccine Adverse Reaction, run by PT Bio Farma at 10 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 14 days after primary series). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.