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Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine

NCT02785705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-05-30

No results posted yet for this study

Summary

Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

poliovirus vaccine

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

Sponsors & Collaborators

  • Air Force Military Medical University, China

    collaborator OTHER

  • Beijing Tiantan Biological Products Co., Ltd.

    collaborator INDUSTRY

  • Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

    lead OTHER_GOV

Principal Investigators

  • Zhaojun Mo · Center of Diseases Control and Prevention (CDC) of Hezhou County and Zhongshan County in Guangxi Zhuang Autonomous Region in China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

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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 NCT02785705 on ClinicalTrials.gov