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Evaluation of Safety and Immunogenicity of Combined Immunization of PPV23 and IIV4

NCT04559204 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1224

Last updated 2022-08-02

No results posted yet for this study

Summary

Subjects will be recruited and divided into 3 groups:

1. Experimental Group (408 subjects): combined immunization of PPV23 and IIV4;
2. Control Group A (408 subjects): IIV4 only;
3. Control Group B (408 subjects): PPV23 only;

All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Conditions

  • Influenza, Human
  • Pneumonia, Pneumococcal

Interventions

BIOLOGICAL

IIV4 and PPV23

imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)

BIOLOGICAL

IIV4

administrated with IIV4 only

BIOLOGICAL

PPV23

administrated with PPV23 only

Sponsors & Collaborators

  • Center for Disease Control and Prevention, Fujian

    collaborator OTHER

  • Chengdu Institute of Biological Products Co.,Ltd.

    collaborator INDUSTRY

  • Changchun Institute of Biological Products Co., Ltd.

    collaborator INDUSTRY

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • Guizhou Center for Disease Control and Prevention

    collaborator OTHER

  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Peking University

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Shanying Zhang · Center for Disease Control and Prevention, Fujian

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2020-11-26
Completion
2021-10-09

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 NCT04559204 on ClinicalTrials.gov