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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05546502
Recruitment Status : Not yet recruiting
First Posted : September 19, 2022
Last Update Posted : October 10, 2022
Sponsor:
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
Information provided by (Responsible Party):
PT Bio Farma

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

Condition or disease Intervention/treatment Phase
Vaccine Reaction Vaccine Adverse Reaction Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine Biological: Active Comparator Phase 3

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,

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Vaccine candidate and active comparator are masking
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Vaccine candidate and active comparator are masking
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : October 8, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

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




Primary Outcome Measures :
  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 [ 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). [ Time Frame: 12 months after primary series ]
    Serious Adverse Event

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05546502


Contacts
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Contact: Rini Mulia Sari, MD 0222033755 ext 14102 rini.mulia@biofarma.co.id
Contact: Mita Puspita, MD 0222033755 ext 5045 mita.puspita@biofarma.co.id

Sponsors and Collaborators
PT Bio Farma
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
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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
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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT05546502    
Other Study ID Numbers: CoV2-Children-0322
First Posted: September 19, 2022    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No