NCT02231632

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

August 1, 2014

Last Update Submit

October 7, 2023

Conditions

Poliomyelitis

Keywords

PoliomyelitisVaccineSafetyefficacy

Outcome Measures

Primary Outcomes (1)

  • Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated

    20 children aged 4 years old and 20 infants aged 2 months were vaccinated with 3 dose of Live attenuated Poliomyelitis vaccine (human diploid cell). Their faeces on day 0,7,30,60 and 90 were collected and incubated in L20B and RD cells for 2 generations, in order to separate and amplify poliovirus I-III Sabin strains in faeces of study objects . Extract total viral RNA from the culture supernatants and detect virogene VP1 through RT-PCR and sequencing ,in order to test the genovariation of vaccinal I-III Sabin strains in faeces after vaccinated .

    up to 90 days

Secondary Outcomes (2)

  • The frequency of all the adverse events in vaccine group and placebo group

    up to 30 days

  • Change of seroconversion from baseline to 3 months

    up to 3 months

Study Arms (2)

Live attenuated Poliomyelitis vaccine (human diploid cell)

EXPERIMENTAL

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).

Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)

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

EXPERIMENTAL

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).

Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)

Interventions

Live attenuated Poliomyelitis vaccine (Human Diploid Cell)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).

Also known as: Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral
Live attenuated Poliomyelitis vaccine (human diploid cell)
Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)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).

Also known as: Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral

Eligibility Criteria

Age2 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kunming, Yunnan, 650118, China

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Qihan Li, Ph.D

    Institude of Medical Biology, Chinese Academy of Medical Sciences

    STUDY CHAIR

  • Jingsi Yang

    Institude of Medical Biology, Chinese Academy of Medical Sciences

    STUDY DIRECTOR

  • Rongcheng Li

    Guangxi Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

September 4, 2014

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

CN(1)