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

NCT05546502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2025-06-03

No results posted yet for this study

Summary

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

Conditions

  • Vaccine Reaction
  • Vaccine Adverse Reaction

Interventions

BIOLOGICAL

SARS-CoV-2 Protein Subunit Recombinant Vaccine

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

BIOLOGICAL

Active Comparator

Covovax

Sponsors & Collaborators

  • Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM

    collaborator UNKNOWN

  • Cipto Mangunkusumo Hospital/Department of Child Health, Faculty of Medicine, University of Indonesia, Jakarta

    collaborator UNKNOWN

  • Faculty of Medicine, Andalas University

    collaborator UNKNOWN

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Cahya Satria, MD · CC PRO UGM

  • Bernie Medise, MD · Fakultas Kedokteran Universitas Indonesia

  • Asrawati Asrawati, MD · Faculty of Medicine Universitas Andalas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-09
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05546502 on ClinicalTrials.gov