COVID-19 trials registries data warehouse

http://en.irct.ir/trial/60331

Dr. Haleh Hamedifar

cinnagen@cinnagen.com

2021-12-29

Completed

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

Chidren, men or women 5 to 40 years Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, and tests Healthy individuals or individuals with stable medical conditions Women eligible to participate in the study who are not pregnant or breastfeeding In children and adolescents aged 5-18, body mass index should be equal percentile or higher, according to WHO child development standards

Subjects with active infection with SARS-COV-2 signs at the screening visit. If subject has history of infection as passed it, involving has no problem People with epilepsy or a history of febrile seizures People who are being treated with immunosuppressive drugs. Among the cytotoxic agents or systemic corticosteroids, for example, for cancer, autoimmune disease or organ transplants or require a specific medical prescription during the study period. Receiving cytotoxic and chemotherapy drugs at any dose will prevent people from entering the study People who have a history of severe allergic reactions (e.g. anaphylaxis) to any components of the vaccine being studied or other drugs Individuals who have received any other research product within 30 days prior to screening visit or intend to participate in another clinical study at the time of this study People who have previously been vaccinated with any type of vaccine against the SARS-CoV-2 virus Individuals who received other authorized vaccines (such as Influenza vaccine or Gardasil) within 28 days prior to the screening visit in this study or intend to receive each vaccine up to 14 days after the second vaccination People who have a known bleeding disorder and who, according to the researcher, may have problems with the intramuscular injection People who have received or intend to receive any blood/plasma or immunoglobulin products during the 90 days prior to the screening visit People with special circumstances who, in the researcher's view, may increase the risk of participating in the study or interfering with the evaluation of the initial objectives of the study People who have donated more than or equal to 450 ml of blood or blood products in the 28 days before the screening visit

2

CinnaGen Company

12

40

Iran

Healthy volunteers

N/A

810

Evaluation of non-inferiority seroconversion for neutralizing antibodies

Not reported

[{"arm_notes": "1mL;2;Days0-21;IM;12-18 years old", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1mL;2;Days0-21;IM;18-40 years old", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]