NCT05546502

Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,050 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

A Phase III, Observer-blind, randomized, active-controlled prospective intervention study

Detailed description

This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study. Main Study for immunogenicity and safety evaluation. Exploratory Study for cellular immunity evaluation,

Conditions

• Vaccine Reaction
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Protein Subunit Recombinant Vaccine	SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
BIOLOGICAL	Active Comparator	Covovax

Timeline

• Start date: 2022-10-09
• Primary completion: 2023-12-31
• Completion: 2024-01-31
• First posted: 2022-09-19
• Last updated: 2025-06-03

Locations

10 sites across 1 country: Indonesia