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Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants

NCT03147560 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2019-09-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.

Conditions

Interventions

BIOLOGICAL

Sabin IPV+ bOPV+ bOPV

Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.

BIOLOGICAL

Sabin IPV + Sabin IPV + bOPV

Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.

BIOLOGICAL

Sabin IPV + Sabin IPV + Sabin IPV

Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.

Sponsors & Collaborators

  • China National Biotec Group Company Limited

    collaborator INDUSTRY

  • Zhejiang Provincial Center for Disease Control and Prevention

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
75 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-02
Primary Completion
2017-12-30
Completion
2017-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03147560 on ClinicalTrials.gov