Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes

NCT05104333 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2021-11-03

No results posted yet for this study

Summary

To evaluate the post-marketing immunogenicity, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.

Conditions

Interventions

BIOLOGICAL

Covid-19 vaccine (0-1-4 schedule)

Subjects receive the booster vaccine 3 months after the second dose.

BIOLOGICAL

Covid-19 vaccine (0-1-6 schedule)

Subjects receive the booster vaccine 5 months after the second dose.

Sponsors & Collaborators

  • Guizhou Center for Disease Control and Prevention

    collaborator OTHER
  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER
  • Center for Disease Control and Prevention, Fujian

    collaborator OTHER
  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY
  • China National Biotec Group Company Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

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 NCT05104333 on ClinicalTrials.gov