Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid System... | NCT05060861

Studies
Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis

NCT05060861

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 29, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

ChAdOx1 nCoV-19 Vaccine

Interventions

ChAdOx1 nCoV-19 vaccine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Oct 30, 2021Estimated

First Submitted Date

Sep 18, 2021

First Submission Date that Met QC Criteria

Sep 18, 2021

First Posted Date

Sep 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2021

Last Update Posted Date

Sep 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
ChAdOx1 nCoV-19 vaccine	Other	covid-19 vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis	the frequency of breakthrough COVID-19 infection	up to one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant who received 2 doses of ChAdOx1 nCoV-19 vaccine

Exclusion Criteria:

non vaccinated person

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Participants aged 18 years and older vaccinated by 2 doses of ChAdOx1 nCoV-19 vaccine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aliae AR Mohamed-Hussein		Asyut		71515	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000090985	ChAdOx1 nCoV-19

Ancestor Terms

ID	Term
D019444	Vaccines, DNA
D000087504	Nucleic Acid-Based Vaccines
D014614	Vaccines, Synthetic
D014612	Vaccines

Browse Leaves

Not provided

Browse Branches

Not provided