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

NCT ID: NCT05546502

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-09
• Study Completion Date: 2024-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

SARS-CoV-2 Protein Subunit Recombinant Vaccine

Intervention Type: BIOLOGICAL

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

Active Comparator

2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose)

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: BIOLOGICAL

Covovax

Interventions

SARS-CoV-2 Protein Subunit Recombinant Vaccine

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

Intervention Type: BIOLOGICAL

Active Comparator

Covovax

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Faculty of Medicine, Andalas University

UNKNOWN

Sponsor Role: collaborator

PT Bio Farma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cahya Satria, MD

Role: PRINCIPAL_INVESTIGATOR

CC PRO UGM

Bernie Medise, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Asrawati Asrawati, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Andalas

Locations

Bali Mandara Hospital

Denpasar, Bali, Indonesia

Universitas Udayana Hospital

Denpasar, Bali, Indonesia

RSUD Hj. Anna Lasmanah

Banjarnegara, Central Java, Indonesia

Abdoel Moeloek Hospital

Bandar Lampung, Lampung, Indonesia

Rumpin Primary Health Care

Bogor, West Java, Indonesia

Duren Seribu Primary Health Care

Depok, West Java, Indonesia

Pasir Putih Primary Health Care

Depok, West Java, Indonesia

Universitas Mataram Hospital

Mataram, West Nusa Tenggara, Indonesia

M Djamil Hospital

Padang, West Sumatra, Indonesia

RS Universitas Andalas

Padang, West Sumatra, Indonesia

Countries

Indonesia

Other Identifiers

CoV2-Children-0322

Identifier Type: -

Identifier Source: org_study_id