Last updated: April 27, 2023
Sponsor: Universidad Peruana Cayetano Heredia
Overall Status: Completed
Phase
3
Condition
Covid-19
Treatment
Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo
Clinical Study ID
NCT04612972
UPeruanaCH
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age range: Healthy subjects aged 18 years old and above
- By asking for medical history and physical examination, the investigator judged thatthe health condition is well
- Female subjects of childbearing age are not nursing or pregnant at the time ofenrolment (negative urine pregnancy test), and do not plan to become pregnant withinthe first 3 months after enrolment . Effective contraceptive measures have been takenwithin 2 weeks before inclusion and continued for at least three month s after lastdose
- During the whole follow up period of the study, be able and willing to complete thewhole prescribed study plan.
- With self ability to understand the research procedures, with informed consent,voluntarily sign an informed consent form, and be able to comply with the requirementsof the clinical study protocol.
Exclusion
Exclusion Criteria:
- SARS CoV 2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection
- SARS CoV 2 Nucleic acid test positive
- Have a history of SARS , MERS infection (self report, on site inquiry
- Fever (axillary temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runnynose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurredwithin 14 days before vaccination
- Axillary body temperature > 37.0 ℃ before vaccination
- Previous severe allergic reactions to vaccination (such as acute allergic reactions,urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to knowningredients of inactivated SARS CoV 2 vaccine have occurred.
- Have a history of convulsion, epilepsy, encephalopathy or mental illness or familyhistory
- Congenital malformations or developmental disorders, genetic defects, severemalnutrition, etc.
- Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignanttumors, various acute diseases or acute attack period of chronic diseases
- Has been diagnosed with congenital or acquired immune deficiency, HIV infection,lymphoma, leukemia or other autoimmune diseases
- Diseases known or suspected include severe respiratory diseases, severe cardiovasculardiseases, liver and kidney diseases, and malignant tumors. - Hist ory of coagulationdysfunction (e.g. Coagulation factor deficiency, coagulation disease)
- Receiving anti TB therapy
- Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oralor infusion for more than 14
- Live attenuated va ccine is inoculated within 1 month before this vaccination , othervaccines are inoculated within 14 days before this vaccination
- Received blood products within 3 months before this vaccination
- Received other research drugs within 6 months before this vacc ination
- Investigator judged other circumstances that are not suitable for this clinical trial.
Study Design
Total Participants: 12000
Treatment Group(s): 1
Primary Treatment: Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo
Phase: 3
Study Start date:
September 09, 2020
Estimated Completion Date:
April 03, 2023
Study Description
Connect with a study center
Av. Honorio Delgado 430, Urb. Ingeniería
San Martin De Porres, Lima L-031
PeruSite Not Available
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