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

NCT05546502 | Completed Phase 3 DMC

• 1 other identifier: CoV2-Children-0322
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Vaccine Reaction; Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine.

  14 days after primary series

• To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).

  28 days after each dose

• To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).

  12 months after primary series

• To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.

  28 days after each dose

• To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.

  28 days after each dose

Study Arms (2)

COVID-19 Protein Subunit Recombinant Vaccine

EXPERIMENTAL

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

Active Comparator

ACTIVE COMPARATOR

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

Biological: Active Comparator

Interventions

SARS-CoV-2 Protein Subunit Recombinant Vaccine BIOLOGICAL

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

COVID-19 Protein Subunit Recombinant Vaccine

Active Comparator BIOLOGICAL

Covovax

Active Comparator

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinically healthy children aged 12-17 years.
• 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).
• Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.

You may not qualify if:

• Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
• History of vaccination with any COVID-19 vaccine (based on anamnesis).
• Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
• Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
• History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
• History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• 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.
• 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)).
• Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
• Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
• Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
• \. Subjects plan to move from the study area before the end of study period.

Sponsors & Collaborators

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

Study Sites (10)

Bali Mandara Hospital

Denpasar, Bali, Indonesia

Location

Universitas Udayana Hospital

Denpasar, Bali, Indonesia

Location

RSUD Hj. Anna Lasmanah

Banjarnegara, Central Java, Indonesia

Location

Abdoel Moeloek Hospital

Bandar Lampung, Lampung, Indonesia

Location

Rumpin Primary Health Care

Bogor, West Java, Indonesia

Location

Duren Seribu Primary Health Care

Depok, West Java, Indonesia

Location

Pasir Putih Primary Health Care

Depok, West Java, Indonesia

Location

Universitas Mataram Hospital

Mataram, West Nusa Tenggara, Indonesia

Location

M Djamil Hospital

Padang, West Sumatra, Indonesia

Location

RS Universitas Andalas

Padang, West Sumatra, Indonesia

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vaccine candidate and active comparator are masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Vaccine candidate and active comparator are masking

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 19, 2022
• Study Start: October 9, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

ID (10)