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

NCT05546502
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,050
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Lead sponsor
PT Bio Farma
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Start date
2022-10-09
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Number of sites
10
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Summary
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
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Short title
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-01-31
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First posted
2022-09-19
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Registry last updated
2025-06-03
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Primary completion date
2023-12-31
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Start date
2022-10-09
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Actual participants
1,050
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Participants
1,050
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
10
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
PT Bio Farma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05546502
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ClinicalTrials.gov ID
NCT05546502
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
Vaccine candidate and active comparator are masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

    Timeframe: 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

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

    Timeframe: 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).

    Timeframe: 28 days after each dose

    Local reactions and systemic events

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

    Timeframe: 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.

    Timeframe: 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.

    Timeframe: 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

    Timeframe: 3, 6 and 12 months after primary series

    SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
12 Years
Maximum age
17 Years
Healthy volunteers
Yes

  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.

  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.

Sources for eligibility
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  • Bali Mandara HospitalDenpasar, Indonesia
  • Universitas Udayana HospitalDenpasar, Indonesia
  • RSUD Hj. Anna LasmanahBanjarnegara, Indonesia
  • Abdoel Moeloek HospitalBandar Lampung, Indonesia
  • Rumpin Primary Health CareBogor, Indonesia
  • Duren Seribu Primary Health CareDepok, Indonesia
  • Pasir Putih Primary Health CareDepok, Indonesia
  • Universitas Mataram HospitalMataram, Indonesia
  • M Djamil HospitalPadang, Indonesia
  • RS Universitas AndalasPadang, Indonesia
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (3)

Lead sponsors (1)