INAVAC - UNAIR Inactivated COVID-19 Vaccine in Healthy Population Aged 12 to 17 Years Old

Tahapan Penelitian : Recruit
Mitra Pelaksana:
Dr. Soetomo General Academic Hospital
No Registry
Tanggal Input Registry : 21-02-2024

Humoral Immune Reponse (Neutralizing antibody): ∙ SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days after the second vaccination
Safety: - Number and percentage of subjects with solicited – clinical (local and systemic) for 30 minutes, 24 hours, 7 and 28 days after each vaccination, and then 3, 6, and 12 months after the second vaccination. - Number and percentage of subjects with unsolicited adverse events (local and systemic) for 30 minutes, 24 hours, 7 and 28 days after each vaccination, and then 3, 6, and 12 months after the second vaccination. - Serious adverse event (SAE) throughout the study (from the first vaccination)
INAVAC - UNAIR Inactivated COVID-19 Vaccine in Healthy Population Aged 12 to 17 Years Old
An Open Label, Phase III Clinical Trial (Immunobridging Study) of INAVAC (Vaksin Merah Putih – UA-SARS CoV-2 (Vero Cell Inactivated)) in Healthy Population Aged 12 to 17 Years Old
INAVAC (Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg)

Inclusion Criteria:

1. Healthy adolescents, age 12 to 17 years old, males and females. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. 2. Subjects and the parents or guardians have been informed properly regarding the study and signed the informed consent and assent forms 3. Subject and the parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial 4. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine. 5. Subjects and the parents or guardians must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial 2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc) 3. Known history of allergy to any component of the vaccines 4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 5. Any autoimmune or immunodeficiency disease/condition 6. Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid – more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted. 7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator. 8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives 9. Individuals who previously receive any vaccines against Covid-19 10. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose 11. Individuals who have a previously ascertained Covid-19 in the period of 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19. 12. Positive test for SARS-CoV-2 (Antigen test or, if necessary, PCR test) at screening prior to first vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator. 13. Alcohol or substance abuse 14. HIV patients. 15. Malignancy patients within 2 years prior to first study vaccination. 16. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc 17. Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision. 18. Women who are pregnant or who plan to become pregnant during the study. 19. Participant has major psychiatric problem or illness 20. Participant cannot communicate reliably with the investigator 21. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia. 22. Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration. 23. Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results 24. Study team members. 25. Subject planning to move from the study area before the end of study period.
Not applicable
PPUK/PPUB number
Dr. Dominicus Husada, dr., DTM&H, MCTM(TP), Sp.A(K)