COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05525208

Rini M. Sari, MD

rini.mulia@biofarma.co.id

2022-09-01

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: clinically healthy adults 18 years of age and older. subjects who have previously received complete primary series of authorized/approved inactivated (sinovac®), mrna (pfizer®), or viral vector covid-19 vaccine (astrazeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion. subjects have been informed properly regarding the study and signed the informed consent form. subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

subject concomitantly enrolled or scheduled to be enrolled in another trial. subject who has received booster dose of covid-19 vaccine. subject who has history of covid-19 in the last 3 months (based on anamnesis or other examinations). evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 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. subjects plan to move from the study area before the end of study period.

6

PT Bio Farma

18

100

Indonesia

Healthy volunteers

N/A

900

Immunogenicity of the candidate vaccine

None

Phase 2

[{"arm_notes": "Subject who had received a complete primary dose of inactivated (Sinovac\u00ae) vaccine", "treatment_id": 2102, "treatment_name": "Subunit recombinant vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "ubject who had received a complete primary dose of mRNA (Pfizer\u00ae) vaccine", "treatment_id": 2102, "treatment_name": "Subunit recombinant vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Subject who had received a complete primary dose of viral vector (AstraZeneca\u00ae) vaccine", "treatment_id": 2102, "treatment_name": "Subunit recombinant vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Subject who had received a complete primary dose of inactivated (Sinovac\u00ae) vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "ubject who had received a complete primary dose of mRNA (Pfizer\u00ae) vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Subject who had received a complete primary dose of viral vector (AstraZeneca\u00ae) vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]