INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old

Launched by DR. SOETOMO GENERAL HOSPITAL · Feb 21, 2024

Keywords

ClinConnect Summary

The INAVAC Vaccine Phase III trial is studying a new vaccine for COVID-19 in healthy adolescents aged 12 to 17. This trial aims to see how well the INAVAC vaccine works in this age group. Participants will receive two doses of the vaccine, given 28 days apart, and will be monitored for a year to track their health and response to the vaccine.

To be eligible for this study, participants must be healthy, meaning they do not have any significant medical conditions or recent illnesses. They also need permission from their parents or guardians and should be willing to follow the study guidelines. This trial is important because it is the first Phase III study of this vaccine specifically in teenagers, helping to ensure that young people have safe and effective options for COVID-19 vaccination.

Gender

FEMALE

Eligibility criteria

• 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.