deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm 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

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

Updated 8 times since 2022 Last updated: Jun 2, 2025 Started: Oct 9, 2022 Primary completion: Dec 31, 2023 Completion: Jan 31, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Vaccine Adverse Reaction and Vaccine Reaction and is currently completed. Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM leads this study, which shows 8 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshotNot Yet Recruiting~Nov 2022 – ~Jan 2023 · 2 months · monthly snapshotNot Yet Recruiting~Jan 2023 – ~May 2023 · 4 months · monthly snapshotRecruiting~May 2023 – ~Jul 2024 · 14 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~May 2025 · 8 months · monthly snapshotRecruiting~May 2025 – ~Jun 2025 · 31 days · monthly snapshotUnknown~Jun 2025 – present · 13 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jun 2025 — Present [monthly]

    Completed PHASE3

    Status: UnknownCompleted

  2. May 2025 — Jun 2025 [monthly]

    Unknown PHASE3

    Status: RecruitingUnknown

  3. Sep 2024 — May 2025 [monthly]

    Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  5. May 2023 — Jul 2024 [monthly]

    Recruiting PHASE3

Show 3 earlier versions
  1. Jan 2023 — May 2023 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  2. Nov 2022 — Jan 2023 [monthly]

    Not Yet Recruiting PHASE3

    Phase: PHASE2_PHASE3PHASE3

  3. Sep 2022 — Nov 2022 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM
  • Cipto Mangunkusumo Hospital/Department of Child Health, Faculty of Medicine, University of Indonesia, Jakarta
  • Faculty of Medicine, Andalas University
  • PT Bio Farma
Data source: PT Bio Farma

For direct contact, visit the study record on ClinicalTrials.gov .