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Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4

NCT04790851 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1133

Last updated 2021-10-20

No results posted yet for this study

Summary

Subjects will be recruited and divided into 3 groups:

Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 only.

Blood samples will be collected 3 times:

before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination.

The immunogenicity and safety of both experimental and control groups will be analyzed.

Conditions

  • Influenza, Human
  • Pneumonia, Pneumococcal
  • Covid19

Interventions

BIOLOGICAL

COVAX+IIV4; COVAX+PPV23

1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23

BIOLOGICAL

COVAX only (1st and 2nd dose)

1st dose: COVAX only; 2nd dose: COVAX only

BIOLOGICAL

IIV4 for the 1st dose and PPV23 for the 2nd dose

1st dose: IIV4 only; 2nd dose: PPV23 only

Sponsors & Collaborators

  • Chengdu Institute of Biological Products Co.,Ltd.

    collaborator INDUSTRY

  • Changchun Institute of Biological Products Co., Ltd.

    collaborator INDUSTRY

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • Sichuan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Shanghai Municipal Center for Disease Control and Prevention

    collaborator OTHER

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Xiaodong Sun · Shanghai Municipal Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2021-09-05
Completion
2021-09-05

Countries

  • China

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 NCT04790851 on ClinicalTrials.gov