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Sisonke (Together): OPEN LABEL TRIAL COVID-19

NCT04838795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 477102

Last updated 2022-08-01

No results posted yet for this study

Summary

To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa

Conditions

  • SARS (Severe Acute Respiratory Syndrome)

Interventions

BIOLOGICAL

To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine

To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa

Sponsors & Collaborators

  • National Department of Health of South Africa

    collaborator UNKNOWN

  • National Institute for Communicable Diseases, South Africa

    collaborator OTHER

  • KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP

    collaborator UNKNOWN

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • Hutchinson Center Research Institute of South Africa (HCRISA)

    collaborator UNKNOWN

  • Janssen Vaccines & Prevention B.V.

    collaborator INDUSTRY

  • Bio Analytical Research Corporation

    collaborator INDUSTRY

  • Dis-Chem Pharmacy

    collaborator UNKNOWN

  • BioVac

    collaborator UNKNOWN

  • Biocair

    collaborator UNKNOWN

  • Right to Care

    collaborator OTHER

  • Clinical Laboratory Services

    collaborator OTHER

  • Wits Health Consortium (Pty) Ltd

    lead OTHER

Principal Investigators

  • Glenda E Gray, MBChB · Non-Executive Director

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838795 on ClinicalTrials.gov