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

NCT ID: NCT02231632

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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 .

Conditions

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Poliomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Live attenuated Poliomyelitis vaccine (human diploid cell)

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).

Group Type EXPERIMENTAL

Live attenuated Poliomyelitis vaccine (Human Diploid Cell)

Intervention Type BIOLOGICAL

6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).

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

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).

Group Type EXPERIMENTAL

Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)

Intervention Type BIOLOGICAL

6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).

Interventions

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Live attenuated Poliomyelitis vaccine (Human Diploid Cell)

6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).

Intervention Type BIOLOGICAL

Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)

6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).

Intervention Type BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* 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

\-
Minimum Eligible Age

2 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangxi Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role collaborator

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qihan Li, Ph.D

Role: STUDY_CHAIR

Institude of Medical Biology, Chinese Academy of Medical Sciences

Jingsi Yang

Role: STUDY_DIRECTOR

Institude of Medical Biology, Chinese Academy of Medical Sciences

Rongcheng Li

Role: PRINCIPAL_INVESTIGATOR

Guangxi Provincial Center for Disease Control and Prevention

Locations

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Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118

Kunming, Yunnan, China

Site Status

Countries

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China

Other Identifiers

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Yangjingsi2014

Identifier Type: -

Identifier Source: org_study_id

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