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

> **NCT05546502** · PHASE3 · COMPLETED · sponsor: **PT Bio Farma** · enrollment: 1050 (actual)

## Conditions studied

- Vaccine Reaction
- Vaccine Adverse Reaction

## Interventions

- **BIOLOGICAL:** SARS-CoV-2 Protein Subunit Recombinant Vaccine
- **BIOLOGICAL:** Active Comparator

## Key facts

- **NCT ID:** NCT05546502
- **Lead sponsor:** PT Bio Farma
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-10-09
- **Primary completion:** 2023-12-31
- **Final completion:** 2024-01-31
- **Target enrollment:** 1050 (ACTUAL)
- **Last updated:** 2025-06-03

## Collaborators

- [object Object]
- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05546502

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05546502, "Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT05546502. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*