- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060861
Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis
September 18, 2021 updated by: Aliae AR Mohamed Hussein, Assiut University
Safety, Efficacy and Immunogenicity of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis
Since the beginning of COVID-19 pandemic, a safe and effective vaccine against infection and development of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is needed control of the wide spread of COVID-19 and reduce death rates throughout the world.
Many clinical trials investigated the immunogenicity of different proposed vaccine including the first distributed vaccine; the ChAdOx1 nCoV-19 vaccine and there is a need to analyze the results of published clinical trials.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt, 71515
- Aliae AR Mohamed-Hussein
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants aged 18 years and older vaccinated by 2 doses of ChAdOx1 nCoV-19 vaccine
Description
Inclusion Criteria:
- Participant who received 2 doses of ChAdOx1 nCoV-19 vaccine
Exclusion Criteria:
- non vaccinated person
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis
Time Frame: up to one year
|
the frequency of breakthrough COVID-19 infection
|
up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
August 30, 2021
Study Completion (Anticipated)
October 30, 2021
Study Registration Dates
First Submitted
September 18, 2021
First Submitted That Met QC Criteria
September 18, 2021
First Posted (Actual)
September 29, 2021
Study Record Updates
Last Update Posted (Actual)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 18, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Assiut19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
upon reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ChAdOx1 nCoV-19 Vaccine
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Beijing Children's HospitalThe First Affiliated Hospital of Anhui Medical University; Shengjing Hospital; China-Japan Friendship Hospital and other collaboratorsUnknown
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Michigan State UniversityRecruitingCOVID-19 | Vaccine-Preventable Diseases | HPVUnited States
-
EyeGene Inc.Novotech (Australia) Pty LimitedActive, not recruiting
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University of OxfordCompletedCOVID-19 | Vaccine ReactionUnited Kingdom
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Leidos Life SciencesUnited States Department of DefenseActive, not recruitingCOVID-19 | Covid19 | Coronavirus Disease 2019 | SARS-CoV-2 Infection | SARS-CoV-2 Acute Respiratory Disease | COVID-19 Pandemic | COVID-19 Virus Infection | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV Disease | 2019-nCoV InfectionUnited States
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University of WashingtonCenters for Disease Control and PreventionRecruitingCOVID-19 | Vaccine HesitancyUnited States
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Stanford UniversityViamoCompletedCOVID-19 Vaccine Knowledge | COVID-19 Vaccine BeliefsUnited States
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Leidos Life SciencesUnited States Department of DefenseWithdrawnCOVID-19 | Covid19 | Coronavirus Disease 2019 | SARS-CoV-2 Infection | SARS-CoV-2 Acute Respiratory Disease | COVID-19 Pandemic | COVID-19 Virus Infection | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV Disease | 2019-nCoV Infection
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Leidos Life SciencesUnited States Department of DefenseTerminatedCOVID-19 | Covid19 | Coronavirus Disease 2019 | SARS-CoV2 Infection | SARS-CoV-2 Acute Respiratory Disease | COVID-19 Pandemic | COVID-19 Virus Infection | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV Disease | 2019-nCoV InfectionUnited States
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Beijing 302 HospitalRecruitingCOVID-19 | Vaccine Reaction | Patients With CancerChina
Clinical Trials on ChAdOx1 nCoV-19 vaccine
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University of OxfordActive, not recruiting
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University of OxfordActive, not recruiting
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Federal University of Espirito SantoInstituto René Rachou/FiocruzRecruiting
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Fundação de Medicina Tropical Dr. Heitor Vieira...Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM); XP Investimentos and other collaboratorsActive, not recruitingHealthy | Comorbidities and Coexisting ConditionsBrazil
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Federal University of Espirito SantoCentro de Pesquisas René Rachou; Secretaria de Estado da Saúde do Espírito...Not yet recruitingCOVID-19 | Vaccine Adverse Reaction | Vaccine-Preventable DiseasesBrazil
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Federal University of Espirito SantoInstituto René Rachou/Fiocruz; Escola Nacional de Saúde Pública Sérgio Arouca... and other collaboratorsRecruiting
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EuBiologics Co.,LtdRecruitingCOVID-19Congo, The Democratic Republic of the
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EuBiologics Co.,LtdActive, not recruiting
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National Taiwan University HospitalTaoyuan General Hospital, Ministry of Health and Welfare,Taoyuan,TaiwanCompletedHealthy Adult VolunteersTaiwan