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

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Center for Child Health-Pediatric Research Office Universitas Gadjah Mada, Fakultas Kedokteran Universitas Andalas, Fakultas Kedokteran Universitas Indonesia
No Registry
INA-FFO44FZ
Tanggal Input Registry : 03-10-2022

06-10-2022
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.
1. To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine. 2. To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). 3. To compare safety and immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group. 4. To evaluate antibody persistence 3, 6 and 12 months after primary series. 5. Exploratory: to assess cellular immunity of the vaccine at baseline, 14 days, 6 months and 12 months after primary series (for Exploratory Study subset).
 
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, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia
Eksperimental
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection; Control group: Covovax – SARS-CoV-2 rS Protein (COVID-19)recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection
1050
 

Inclusion Criteria:

1. Clinically healthy children aged 12-17 years. 2. Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject). 3. Parent/legal guardian and subject 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. History of COVID-19 within 3 months prior to enrollment (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). 12. Subjects plan to move from the study area before the end of study period.
 
KE/FK/1109/EC, 967/UN.16.2/KEP-FK/2022
N.A
RG.01.06.1.2.09.22.164
CoV2-Children-0322
dr. Cahya Dewi Satria, M.Kes., Sp.A(K); dr. Asrawati, M.Biomed., Sp.A(K); Dr. dr. Bernie Endyarni Medise, SpA(K), MPH