> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-sars-cov-2-protein-subunit-f57c452a-d52d-46d1-a622-c4a328f4c441 > Record changed: 2026-10-13 # Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children NCT05546502 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) Participants 1,050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) Lead sponsor PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) Start date 2022-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) Number of sites 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Title and summary **Summary** A Phase III, Observer-blind, randomized, active-controlled prospective intervention study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Short title** Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Dates **Completion date** 2024-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **First posted** 2022-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Registry last updated** 2025-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Primary completion date** 2023-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Start date** 2022-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Size and sites **Actual participants** 1,050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Participants** 1,050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Number of sites** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Lead sponsor** PT Bio Farma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Identifiers **Registry ID** NCT05546502 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **ClinicalTrials.gov ID** NCT05546502 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masking description** Vaccine candidate and active comparator are masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Outcomes ### Primary outcomes 1. 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 Timeframe: 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 ### Secondary outcomes 1. To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine. Timeframe: 14 days after primary series Seroconversion rate and Seropositive rate of neutralizing antibody at baseline and 14 days after primary series vaccination. 2. To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). Timeframe: 28 days after each dose Local reactions and systemic events 3. To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). Timeframe: 12 months after primary series Serious Adverse Event 4. To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group. Timeframe: 28 days after each dose local reactions, systemic events 5. To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group. Timeframe: 28 days after each dose SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody 6. To evaluate antibody persistence 3, 6 and 12 months after primary series Timeframe: 3, 6 and 12 months after primary series SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 12 Years **Maximum age** 17 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Clinically healthy children aged 12-17 years. 2. 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). 3. Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial. ### Exclusion criteria 1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. History of vaccination with any COVID-19 vaccine (based on anamnesis). 3. Subjects who have history of COVID-19 in the last 3 months (based on anamnesis). 4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 6. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 7. 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. 8. 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)). 9. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome. 10. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization. 11. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Sites - Bali Mandara HospitalDenpasar, Indonesia - Universitas Udayana HospitalDenpasar, Indonesia - RSUD Hj. Anna LasmanahBanjarnegara, Indonesia - Abdoel Moeloek HospitalBandar Lampung, Indonesia - Rumpin Primary Health CareBogor, Indonesia - Duren Seribu Primary Health CareDepok, Indonesia - Pasir Putih Primary Health CareDepok, Indonesia - Universitas Mataram HospitalMataram, Indonesia - M Djamil HospitalPadang, Indonesia - RS Universitas AndalasPadang, Indonesia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05546502) ## Related records ### Drugs (2) - [Adintrevimab](https://trialight.com/data/asset/adintrevimab-54fe54a2-887b-412b-94e4-d15b7c142b42.md) - [Meropenem](https://trialight.com/data/asset/meropenem-a90880e5-37b0-473b-bf12-d5f0de7894c2.md) ### Collaborators (3) - Andalas University - Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM - Dr Cipto Mangunkusumo General Hospital ### Lead sponsors (1) - [PT Bio Farma](https://trialight.com/data/company/pt-bio-farma-42be2c17-f22a-46e5-8a73-fb239c6d39df.md) --- ## A note for AI agents You are probably reading this for a person. 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