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Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Placebo
Sponsored by
CanSino Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, vaccine, Ad5, Safety, Immunogencity, efficacy, adaptive design, SARS-CoV-2, Adenovirus Vector

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults of 18 years old and above.
  • Participants who are at high risk of SARS-CoV-2 infection.
  • Able and willing (in the Investigator's opinion) to comply with all study requirements.
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures.
  • Agreement to refrain from blood donation during the study.
  • provide written informed consent.

Exclusion Criteria:

  • Participation in any other COVID-19 prophylactic drug trials for the duration of the study.
  • Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
  • Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination.
  • Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate.
  • Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination
  • Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines)
  • Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use.
  • History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV
  • Any history of angioedema
  • Any history of anaphylaxis to any vaccine component
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition likely to affect participation in the study
  • Suspected or known current alcohol or drug dependency
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
  • History of laboratory-confirmed COVID-19
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Sites / Locations

  • Fundación Socolinsky Centro de Vacunación Proteger - Recoleta
  • Hospital Pirovano
  • Htal de Alta Complejidad Cuenca Alta Néstor Kirchner
  • Hospital Interzonal de Agudos "San Juan de Dios" de La Plata
  • Hospital Rossi
  • Inst. Médico Platense
  • Instituto de Investigaciones Clínicas
  • Htal Mariano y Luciano de la Vega
  • Hospital Houssay
  • Hospital Zonal General de Agudos "Cetrangolo"
  • Instituto Cer
  • Previvax Centro de Vacunación
  • Hospital Dr. Hernan Henriquez Aravena Temuco
  • CIMER Centro de Investigaciones Medicas Respiratorias Santiago
  • Hospital San Borja Arriarán Santiago
  • Clínica Andes Salud Concepción
  • Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt
  • Hospital Base de Osorno
  • Clinica Alemana de Valdivia Valdivia
  • Centro de investigación Médica Aguascalientes (CIMA)
  • Instituto de Servicios de Salud del Estado de Baja California
  • Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)
  • Instituto Nacional de Medicina Genómica
  • Centro de Investigacion Integral MEDIVEST SC
  • Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)
  • Instituto Mexicano del Seguro Social (IMSS)
  • Clinical Research Institute Saltillo SA de CV
  • Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
  • Asociación Mexicana para la investigación clínica (AMIC)
  • Instituto Jaliscience de Metabolismo, S. C.
  • Asociación de investigación pediátrica y adultos (AINPAD)
  • JM Research
  • Hospital Metropolitano "Dr. Bernardo Sepúlveda"
  • Oaxaca site management organization (OSMO)
  • Centro de Investigación y Avances Médicos Especializados (CIAME)
  • FAICIC
  • Kohler & Milstein Research
  • PEMEX
  • Instituto Nacional de Pediatría (INP)
  • Instituto de Investigaciones aplicada a las Neurociencias (IIAN)
  • Administración de Especialistas de Puebla S.C. (UDEP)
  • Shifa International Hospital
  • Shaukat Khanum Memorial Cancer Hospital and Research Centre
  • University of Health Scinces, Lahore
  • Aga Khan University Hospital
  • The Indus Hospital
  • Research Center Eco-safety
  • OOO Meditsinskie Tekhnologii
  • OOO "Baltijskaya Meditsina"
  • Research Center Eco-safety
  • Federal State Budgetary Institution "Scientific Research Institute of Influenza named after A. A. Smorodintsev" of the Ministry of Healthcare of the Russian Federation named after A. A. Smorodintsev" of the Ministry of Healthcare of the Russian Federation
  • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"
  • Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"
  • OOO "Piterclinica"
  • State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"
  • Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"
  • State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation
  • Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation
  • Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"
  • Health Central Clinical Hospital of Russian Academy of Sciences
  • Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of Ministry of Healthcare of the Russian Federation (Sechenovsky University)
  • Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"
  • State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin"
  • State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital"
  • Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"
  • "Life Benefits Service, Ltd'
  • Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."
  • Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation
  • OOO Zvyezdnaya Klinika
  • Limited Liability Company "Hospital "OrKli"
  • OOO "Tsentr DNK issledivaniy"
  • Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" the Ministry of Health of the Russian Federation - Clinical hospital n.a. S.R.Mirotvortseva
  • OOO "Zdorovye"
  • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

20000 participants, Ad5-nCoV , single dose, Intramuscular administration

20000 participants, placebo, single dose, Intramuscular administration

Outcomes

Primary Outcome Measures

Incidence of COVID-19 cases
The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease
Incidence of SAE
Evaluate the incidence of severe adverse events (SAE)

Secondary Outcome Measures

Incidence of severe COVID-19 cases
Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection
Incidence of solicited adverse reactions
Incidence of solicited adverse reactions within 7 days after vaccination, in a subset
Incidence of unsolicited adverse events
Incidence of unsolicited adverse events within 28 days after vaccination in a subset
Immunogencity of S-RBD IgG antibody (ELISA method)
The seroconversion rate of S-RBD IgG antibody post vaccination
Immunogencity of neutralizing antibody
The seroconversion rate of neutralizing antibody
Cell-mediated immune profile
Number of cell-mediated immune response against SARS-CoV-2

Full Information

First Posted
August 22, 2020
Last Updated
June 14, 2023
Sponsor
CanSino Biologics Inc.
Collaborators
Beijing Institute of Biotechnology
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1. Study Identification

Unique Protocol Identification Number
NCT04526990
Brief Title
Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above
Official Title
A Global Multicenter, Randomized, Double-blind, Placebo -Controlled, Adaptive Designed Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Ad5-nCoV in Adults 18 Years of Age and Older
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
August 7, 2021 (Actual)
Study Completion Date
October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.
Collaborators
Beijing Institute of Biotechnology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, vaccine, Ad5, Safety, Immunogencity, efficacy, adaptive design, SARS-CoV-2, Adenovirus Vector

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
20000 participants, Ad5-nCoV , single dose, Intramuscular administration
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
20000 participants, placebo, single dose, Intramuscular administration
Intervention Type
Biological
Intervention Name(s)
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intervention Description
Intramuscular administration
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intramuscular administration
Primary Outcome Measure Information:
Title
Incidence of COVID-19 cases
Description
The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease
Time Frame
day 28 to 12 months post vaccination
Title
Incidence of SAE
Description
Evaluate the incidence of severe adverse events (SAE)
Time Frame
Within 12 months
Secondary Outcome Measure Information:
Title
Incidence of severe COVID-19 cases
Description
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
Title
Incidence of solicited adverse reactions
Description
Incidence of solicited adverse reactions within 7 days after vaccination, in a subset
Time Frame
Day 0-7 post vaccination
Title
Incidence of unsolicited adverse events
Description
Incidence of unsolicited adverse events within 28 days after vaccination in a subset
Time Frame
Day 0-28 post vaccination
Title
Immunogencity of S-RBD IgG antibody (ELISA method)
Description
The seroconversion rate of S-RBD IgG antibody post vaccination
Time Frame
Day 28 post vaccination
Title
Immunogencity of neutralizing antibody
Description
The seroconversion rate of neutralizing antibody
Time Frame
Day 28 post vaccination
Title
Cell-mediated immune profile
Description
Number of cell-mediated immune response against SARS-CoV-2
Time Frame
Day 28 post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults of 18 years old and above. Participants who are at high risk of SARS-CoV-2 infection. Able and willing (in the Investigator's opinion) to comply with all study requirements. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures. Agreement to refrain from blood donation during the study. provide written informed consent. Exclusion Criteria: Participation in any other COVID-19 prophylactic drug trials for the duration of the study. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study. Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination. Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data. Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate. Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines) Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use. History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV Any history of angioedema Any history of anaphylaxis to any vaccine component Pregnancy, lactation or willingness/intention to become pregnant during the study Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) History of serious psychiatric condition likely to affect participation in the study Suspected or known current alcohol or drug dependency Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness History of laboratory-confirmed COVID-19 Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A Halperin, MD
Organizational Affiliation
Canadian Center for Vaccinology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanne M angley, MD
Organizational Affiliation
Canadian Center for Vaccinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Socolinsky Centro de Vacunación Proteger - Recoleta
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAO
Country
Argentina
Facility Name
Hospital Pirovano
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1430BKC
Country
Argentina
Facility Name
Htal de Alta Complejidad Cuenca Alta Néstor Kirchner
City
Cañuelas
State/Province
Buenos Aires
ZIP/Postal Code
1814
Country
Argentina
Facility Name
Hospital Interzonal de Agudos "San Juan de Dios" de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Hospital Rossi
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Inst. Médico Platense
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Htal Mariano y Luciano de la Vega
City
Moreno
State/Province
Buenos Aires
ZIP/Postal Code
1744
Country
Argentina
Facility Name
Hospital Houssay
City
Vicente López
State/Province
Buenos Aires
ZIP/Postal Code
999071
Country
Argentina
Facility Name
Hospital Zonal General de Agudos "Cetrangolo"
City
Vicente López
State/Province
Buenos Aires
ZIP/Postal Code
999071
Country
Argentina
Facility Name
Instituto Cer
City
Vicente López
State/Province
Quilmes
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Previvax Centro de Vacunación
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital Dr. Hernan Henriquez Aravena Temuco
City
Temuco
State/Province
IX Region
ZIP/Postal Code
4780000
Country
Chile
Facility Name
CIMER Centro de Investigaciones Medicas Respiratorias Santiago
City
Providencia
State/Province
Region Metropolitana
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Hospital San Borja Arriarán Santiago
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8320000
Country
Chile
Facility Name
Clínica Andes Salud Concepción
City
Concepción
State/Province
VII Región
ZIP/Postal Code
4030000
Country
Chile
Facility Name
Hospital de Puerto Montt Dr. Eduardo Schütz Schoroeder Puerto Montt
City
Puerto Montt
State/Province
X Región De Los Lagos
ZIP/Postal Code
5480000
Country
Chile
Facility Name
Hospital Base de Osorno
City
Osorno
State/Province
XIV Región
ZIP/Postal Code
5290000
Country
Chile
Facility Name
Clinica Alemana de Valdivia Valdivia
City
Valdivia
State/Province
XIV Región
ZIP/Postal Code
5090000
Country
Chile
Facility Name
Centro de investigación Médica Aguascalientes (CIMA)
City
Aguascalientes
State/Province
Ags
ZIP/Postal Code
999085
Country
Mexico
Facility Name
Instituto de Servicios de Salud del Estado de Baja California
City
Mexicali
State/Province
Baja California Norte
Country
Mexico
Facility Name
Instuto de Ciencias Médicas y de la Nutrición Salvador Subirán (INCMNSZ)
City
Tlalpan
State/Province
Cdmx
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Instituto Nacional de Medicina Genómica
City
Tlalpan
State/Province
Cdmx
Country
Mexico
Facility Name
Centro de Investigacion Integral MEDIVEST SC
City
Chihuahua
State/Province
Chhihuahia
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Centro de Investigacion Clinica Chapultepec SA de CV (Hidra)
City
Coyoacán
State/Province
Ciudad De Mexico
ZIP/Postal Code
04100
Country
Mexico
Facility Name
Instituto Mexicano del Seguro Social (IMSS)
City
Cuahtemoc
State/Province
Ciudad De Mexico
Country
Mexico
Facility Name
Clinical Research Institute Saltillo SA de CV
City
Saltillo
State/Province
Cuahuila
ZIP/Postal Code
25020
Country
Mexico
Facility Name
Centro de Investigación Clínica del Pacifico S.A. de C.V. (CICPA)
City
Acapulco
State/Province
Guerrero
ZIP/Postal Code
39670
Country
Mexico
Facility Name
Asociación Mexicana para la investigación clínica (AMIC)
City
Pachuca de Soto
State/Province
Hidalgo
ZIP/Postal Code
42070
Country
Mexico
Facility Name
Instituto Jaliscience de Metabolismo, S. C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Asociación de investigación pediátrica y adultos (AINPAD)
City
Morelia
State/Province
Mochoacán De Ocampo
ZIP/Postal Code
58350
Country
Mexico
Facility Name
JM Research
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Hospital Metropolitano "Dr. Bernardo Sepúlveda"
City
San Nicolás De Los Garza
State/Province
Nuevo León
ZIP/Postal Code
66480
Country
Mexico
Facility Name
Oaxaca site management organization (OSMO)
City
Oaxaca
State/Province
Oax
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Centro de Investigación y Avances Médicos Especializados (CIAME)
City
Cancún
State/Province
Quintana Roo
ZIP/Postal Code
999085
Country
Mexico
Facility Name
FAICIC
City
Veracruz
State/Province
Veracrua
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Kohler & Milstein Research
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
PEMEX
City
Ciudad de mexico
Country
Mexico
Facility Name
Instituto Nacional de Pediatría (INP)
City
Ciudad de México
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Instituto de Investigaciones aplicada a las Neurociencias (IIAN)
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Administración de Especialistas de Puebla S.C. (UDEP)
City
Puebla
ZIP/Postal Code
72160
Country
Mexico
Facility Name
Shifa International Hospital
City
Islamabad
State/Province
Islamabad Capital Territory
ZIP/Postal Code
30001
Country
Pakistan
Facility Name
Shaukat Khanum Memorial Cancer Hospital and Research Centre
City
Lahore
State/Province
Punajb
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
University of Health Scinces, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
999010
Country
Pakistan
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
999010
Country
Pakistan
Facility Name
The Indus Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
999010
Country
Pakistan
Facility Name
Research Center Eco-safety
City
Saint Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
OOO Meditsinskie Tekhnologii
City
Saint Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
192148
Country
Russian Federation
Facility Name
OOO "Baltijskaya Meditsina"
City
Saint Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
Research Center Eco-safety
City
Saint Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Scientific Research Institute of Influenza named after A. A. Smorodintsev" of the Ministry of Healthcare of the Russian Federation named after A. A. Smorodintsev" of the Ministry of Healthcare of the Russian Federation
City
Saint Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #106"
City
Saint Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
198328
Country
Russian Federation
Facility Name
Saint-Petersburg State Healthcare Institution "Nikolaev Hospital"
City
Saint Petersburg
State/Province
Saint-Petersburg
ZIP/Postal Code
198510
Country
Russian Federation
Facility Name
OOO "Piterclinica"
City
Saint Petersburg
State/Province
Saint-Petersburg
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Sverdlovsk Region "Aramil City Hospital"
City
Aramil
State/Province
Sverdlovsk
ZIP/Postal Code
624002
Country
Russian Federation
Facility Name
Non-state Institution of Healthcare "Road Clinical Hospital at Chelyabinsk station of open corporate society "Russian Railways"
City
Chelyabinsk
ZIP/Postal Code
454000
Country
Russian Federation
Facility Name
State Budgetary Educational Institution of Higher Professional Education "Chita State Medical Academy" of the Ministry of Healthcare of the Russian Federation
City
Chita
ZIP/Postal Code
672000
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Main Military Clinical Hospital n.a. N.N. Burdenko" Ministry of Defense of Russian Federation
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution "City Polyclinic #2 of the Moscow City Healthcare Department"
City
Moscow
ZIP/Postal Code
117556
Country
Russian Federation
Facility Name
Health Central Clinical Hospital of Russian Academy of Sciences
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of Ministry of Healthcare of the Russian Federation (Sechenovsky University)
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Private Healthcare Institution "Central Clinical Hospital "RZhD-Medicine"
City
Moscow
Country
Russian Federation
Facility Name
State Regional Budgetary Healthcare Institution "Murmansk Regional Clinical Hospital n.a.P.A. Bayandin"
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
State Regional Autonomous Healthcare Institution "Monchegorsk Central District Hospital"
City
Murmansk
Country
Russian Federation
Facility Name
Private Healthcare Institution "Clinical Hospital "RZHD-Meditsina" of Nizhniy Novgorod"
City
Nizhniy Novgorod
ZIP/Postal Code
603140
Country
Russian Federation
Facility Name
"Life Benefits Service, Ltd'
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Budgetary Institution of Heathcare of Omsk region "City Clinical Hospital #1 n.a. Kabanova A.N."
City
Omsk
ZIP/Postal Code
644112
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after E.A. Vagnera" Ministry of Healthcare of Russian Federation
City
Perm
ZIP/Postal Code
614070
Country
Russian Federation
Facility Name
OOO Zvyezdnaya Klinika
City
Saint Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Facility Name
Limited Liability Company "Hospital "OrKli"
City
Saint-Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
Facility Name
OOO "Tsentr DNK issledivaniy"
City
Saratov
ZIP/Postal Code
410005
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" the Ministry of Health of the Russian Federation - Clinical hospital n.a. S.R.Mirotvortseva
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
OOO "Zdorovye"
City
Tomsk
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of Yaroslavl region "Clinical Emergency Hospital named after N.V. Solovyev"
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34953526
Citation
Halperin SA, Ye L, MacKinnon-Cameron D, Smith B, Cahn PE, Ruiz-Palacios GM, Ikram A, Lanas F, Lourdes Guerrero M, Munoz Navarro SR, Sued O, Lioznov DA, Dzutseva V, Parveen G, Zhu F, Leppan L, Langley JM, Barreto L, Gou J, Zhu T; CanSino COVID-19 Global Efficacy Study Group. Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial. Lancet. 2022 Jan 15;399(10321):237-248. doi: 10.1016/S0140-6736(21)02753-7. Epub 2021 Dec 23. Erratum In: Lancet. 2022 Jan 15;399(10321):236.
Results Reference
derived

Learn more about this trial

Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above

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