NCT06282692

INAVAC Vaccine Phase III (Immunobridging Study) 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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: Female
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.

Detailed description

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. This study will have three interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 12 months after the second dose.

Conditions

• COVID-19 Pandemic
• COVID-19 Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg	Dose : 1 dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride.

Timeline

• Start date: 2023-06-19
• Primary completion: 2024-05-19
• Completion: 2024-07-19
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: Indonesia