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Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

NCT04053010 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2019-08-12

No results posted yet for this study

Summary

Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.

Conditions

  • Vaccination

Interventions

BIOLOGICAL

Sabin-IPV and DTaP

Sabin-IPV +DTaP at the age of 3/4/5 months old respectively

BIOLOGICAL

Sabin-IPV

Sabin-IPV only at the age of 3/4/5 months old respectively

BIOLOGICAL

DTaP

DTaP only at the age of 3/4/5 months old respectively

Sponsors & Collaborators

  • Wuhan Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Hubei Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Shaobai ZHANG · Shaanxi Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-10
Primary Completion
2019-12-31
Completion
2020-05-30

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 NCT04053010 on ClinicalTrials.gov