The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)

Institute of Medical Biology, Chinese Academy of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Poliomyelitis

Treatments: Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell); Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)

Study type: Interventional

Funder types: Other

Identifiers

NCT02231632

Yangjingsi2014

Details and patient eligibility

About

The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)

Full description

Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase 2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .

Enrollment: 1,200 patients

Sex: All

Ages: 2 to 4 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Only subjects fulfilling all of the following criteria will be eligible for the study:

• People aged from 2 months to 4 months old.
• The subjects or subjects' guardians are able to understand and sign the informed consent
• The subjects or subjects' guardians allow to comply with the requirements of the protocol
• Subjects with temperature <=37.0°C on axillary setting
• The subjects have signed informed consent already

Exclusion Criteria:The subjects have never been vaccinated with any Poliomyelitis Vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,200 participants in 2 patient groups

Live attenuated Poliomyelitis vaccine (human diploid cell)

Experimental group

Description:

6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).

Treatment:

Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)

Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral

Experimental group

Description:

6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).

Treatment:

Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)