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

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

Study Overview

• Status: Completed
• Conditions: Vaccine Adverse Reaction; Vaccine Reaction
• Intervention / Treatment: Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine; Biological: Active Comparator

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,

• Study Type: Interventional
• Enrollment (Actual): 1050
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia
      • Bali Mandara Hospital
    • Denpasar, Bali, Indonesia
      • Universitas Udayana Hospital
  • Central Java
    • Banjarnegara, Central Java, Indonesia
      • RSUD Hj. Anna Lasmanah
  • Lampung
    • Bandar Lampung, Lampung, Indonesia
      • Abdoel Moeloek Hospital
  • West Java
    • Bogor, West Java, Indonesia
      • Rumpin Primary Health Care
    • Depok, West Java, Indonesia
      • Duren Seribu Primary Health Care
    • Depok, West Java, Indonesia
      • Pasir Putih Primary Health Care
  • West Nusa Tenggara
    • Mataram, West Nusa Tenggara, Indonesia
      • Universitas Mataram Hospital
  • West Sumatra
    • Padang, West Sumatra, Indonesia
      • M Djamil Hospital
    • Padang, West Sumatra, Indonesia
      • RS Universitas Andalas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Clinically healthy children aged 12-17 years.
2. Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years).
3. Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any COVID-19 vaccine (based on anamnesis).
3. Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
6. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
7. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
8. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
9. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
10. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
11. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).

11. Subjects plan to move from the study area before the end of study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID-19 Protein Subunit Recombinant Vaccine; 2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)	Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine; SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Active Comparator: Active Comparator; 2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose)	Biological: Active Comparator; Covovax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series	Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2, measured by neutralization assay (against omicron variant) at 14 days after primary series	14 days after primary series

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine.	Seroconversion rate and Seropositive rate of neutralizing antibody at baseline and 14 days after primary series vaccination.	14 days after primary series
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).	Local reactions and systemic events	28 days after each dose
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).	Serious Adverse Event	12 months after primary series
To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.	local reactions, systemic events	28 days after each dose
To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.	SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody	28 days after each dose
To evaluate antibody persistence 3, 6 and 12 months after primary series	SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody	3, 6 and 12 months after primary series

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: 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
• Investigators: Principal Investigator: Cahya Satria, MD, CC PRO UGM; Principal Investigator: Bernie Medise, MD, Fakultas Kedokteran Universitas Indonesia; Principal Investigator: Asrawati Asrawati, MD, Faculty of Medicine Universitas Andalas

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CoV2-Children-0322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No