MedTrace Logo

Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

NCT04054882 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2022-07-07

No results posted yet for this study

Summary

Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only.

After finishing the two basic vaccine EPI procedures, the immunogenicity and safety of both combined immunization group and individual vaccination groups will be compared and the data will be analyzed.

Conditions

  • Vaccination

Interventions

BIOLOGICAL

Sabin-IPV and DTaP

simultaneously administration of Sabin-IPV and DTaP

BIOLOGICAL

Sabin-IPV

administration of Sabin-IPV only

BIOLOGICAL

DTaP

administration of DTaP only

Sponsors & Collaborators

  • Chengdu Institute of Biological Products Co.,Ltd.

    collaborator INDUSTRY

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • Jiangsu Province Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Anhui Provincial Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Sichuan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Peking University

    collaborator OTHER

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Fenyang Tang · Jiangsu 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
2019-08-16
Primary Completion
2020-03-30
Completion
2021-09-09

Countries

  • China

Study Locations

More Related Trials

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 NCT04054882 on ClinicalTrials.gov