- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Bali
-
Denpasar, Bali, Indonesia
- Active, not recruiting
- Bali Mandara Hospital
-
Denpasar, Bali, Indonesia
- Active, not recruiting
- Universitas Udayana Hospital
-
-
Central Java
-
Banjarnegara, Central Java, Indonesia
- Active, not recruiting
- RSUD Hj. Anna Lasmanah
-
-
Lampung
-
Bandar Lampung, Lampung, Indonesia
- Active, not recruiting
- Abdoel Moeloek Hospital
-
-
West Java
-
Bogor, West Java, Indonesia
- Recruiting
- Rumpin Primary Health Care
-
Contact:
- Bernie Medise, MD
-
Depok, West Java, Indonesia
- Active, not recruiting
- Duren Seribu Primary Health Care
-
Depok, West Java, Indonesia
- Recruiting
- Pasir Putih Primary Health Care
-
Contact:
- Bernie Medise, MD
-
-
West Nusa Tenggara
-
Mataram, West Nusa Tenggara, Indonesia
- Active, not recruiting
- Universitas Mataram Hospital
-
-
West Sumatra
-
Padang, West Sumatra, Indonesia
- Active, not recruiting
- M Djamil Hospital
-
Padang, West Sumatra, Indonesia
- Active, not recruiting
- RS Universitas Andalas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
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
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)
|
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)
|
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
Time Frame: 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.
Time Frame: 14 days after primary series
|
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).
Time Frame: 28 days after each dose
|
Local reactions and systemic events
|
28 days after each dose
|
To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
Time Frame: 12 months after primary series
|
Serious Adverse Event
|
12 months after primary series
|
To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.
Time Frame: 28 days after each dose
|
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.
Time Frame: 28 days after each dose
|
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
Time Frame: 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
Collaborators
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)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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