Clinical trial NCT05546502: Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccine Reaction
Vaccine Adverse Reaction
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM
name: Cipto Mangunkusumo Hospital/Department of Child Health, Faculty of Medicine, University of Indonesia, Jakarta
name: Faculty of Medicine, Andalas University
First posted: 2022-09-19
Enrollment: 1050
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Vaccine candidate and active comparator are masking
Primary purpose: PREVENTION

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,

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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
measure: To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
timeFrame: 28 days after each dose
measure: To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).
timeFrame: 12 months after primary series
measure: To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.
timeFrame: 28 days after each dose
measure: To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.
timeFrame: 28 days after each dose
measure: To evaluate antibody persistence 3, 6 and 12 months after primary series
timeFrame: 3, 6 and 12 months after primary series
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Bali Mandara Hospital
state: Bali
city: Denpasar
country: Indonesia
facility: Universitas Udayana Hospital
state: Bali
city: Banjarnegara
country: Indonesia
facility: RSUD Hj. Anna Lasmanah
state: Central Java
city: Bandar Lampung
country: Indonesia
facility: Abdoel Moeloek Hospital
state: Lampung
city: Bogor
country: Indonesia
facility: Rumpin Primary Health Care
state: West Java
city: Depok
country: Indonesia
facility: Duren Seribu Primary Health Care
state: West Java
city: Depok
country: Indonesia
facility: Pasir Putih Primary Health Care
state: West Java
city: Mataram
country: Indonesia
facility: Universitas Mataram Hospital
state: West Nusa Tenggara
city: Padang
country: Indonesia
facility: M Djamil Hospital
state: West Sumatra
city: Padang
country: Indonesia
facility: RS Universitas Andalas
state: West Sumatra
Study officials:
affiliation: CC PRO UGM
name: Cahya Satria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Bernie Medise, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine Universitas Andalas
name: Asrawati Asrawati, MD
role: PRINCIPAL_INVESTIGATOR
References: