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Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

NCT03902054 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-04-03

No results posted yet for this study

Summary

This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60\~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Conditions

  • Polio and Post-Polio Syndrome

Interventions

BIOLOGICAL

Three-dose regimen of high dosage investigational sIPV

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

BIOLOGICAL

Three-dose regimen of medium dosage investigational sIPV

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

BIOLOGICAL

Three-dose regimen of low dosage investigational sIPV

The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..

BIOLOGICAL

Three-dose regimen of commercialized sIPV

The control vaccine was manufactured by Chinese Academy of Medical Sciences.

BIOLOGICAL

Three-dose regimen of commercialized IPV

The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).

Sponsors & Collaborators

  • Beijing Minhai Biotechnology Co., Ltd

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2018-05-26
Completion
2018-12-28

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 NCT03902054 on ClinicalTrials.gov