This study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.
This is a global phase III clinical trial to evaluate efficacy,safety, immuogenicity of Ad5-nCoV manufactured by Cansino and Beijing Institute of Biotechnology in health adults aged 18 years old and above. The study will be double-blind, placebo-controlled trial with participants randomly allocated 1:1 to placebo and experimental vaccine cohorts. The immunization schedule is one doses intramuscular injections (deltoid).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
44,247
Intramuscular administration
Intramuscular administration
Incidence of COVID-19 cases
The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease
Time frame: day 28 to 12 months post vaccination
Incidence of SAE
Evaluate the incidence of severe adverse events (SAE)
Time frame: Within 12 months
Incidence of severe COVID-19 cases
Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection
Time frame: Day 14 to 12 months post vaccination
Incidence of solicited adverse reactions
Incidence of solicited adverse reactions within 7 days after vaccination, in a subset
Time frame: Day 0-7 post vaccination
Incidence of unsolicited adverse events
Incidence of unsolicited adverse events within 28 days after vaccination in a subset
Time frame: Day 0-28 post vaccination
Immunogencity of S-RBD IgG antibody (ELISA method)
The seroconversion rate of S-RBD IgG antibody post vaccination
Time frame: Day 28 post vaccination
Immunogencity of neutralizing antibody
The seroconversion rate of neutralizing antibody
Time frame: Day 28 post vaccination
Cell-mediated immune profile
Number of cell-mediated immune response against SARS-CoV-2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fundación Socolinsky Centro de Vacunación Proteger - Recoleta
CABA, Buenos Aires, Argentina
Hospital Pirovano
CABA, Buenos Aires, Argentina
Htal de Alta Complejidad Cuenca Alta Néstor Kirchner
Cañuelas, Buenos Aires, Argentina
Hospital Interzonal de Agudos "San Juan de Dios" de La Plata
La Plata, Buenos Aires, Argentina
Hospital Rossi
La Plata, Buenos Aires, Argentina
Inst. Médico Platense
La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas
Mar del Plata, Buenos Aires, Argentina
Htal Mariano y Luciano de la Vega
Moreno, Buenos Aires, Argentina
Hospital Houssay
Vicente López, Buenos Aires, Argentina
Hospital Zonal General de Agudos "Cetrangolo"
Vicente López, Buenos Aires, Argentina
...and 64 more locations
Time frame: Day 28 post vaccination