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

Poliomyelitis Clinical Trial

Official title:

Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231632
• Other study ID #: Yangjingsi2014
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2023
• Source: Institute of Medical Biology, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 4 Months

Eligibility

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.

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Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• 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).
• 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).

Locations

Country	Name	City	State
China	Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118	Kunming	Yunnan

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Medical Biology, Chinese Academy of Medical Sciences	Guangxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The frequency of all the adverse events in vaccine group and placebo group	compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.	up to 30 days
Secondary	Change of seroconversion from baseline to 3 months	Randomly chose 600 infants respectively from two study arms, get 2.5ml of the blood on the first day and 3 months during vaccination .Reciprocal antibody titers of at least 1:8, the lowest detectable titer, is considered to indicate seropositivity with regards to the presence of poliovirus neutralizing antibodies. Seroconversion is defined as either seronegative participants (<1:8 titers) who become seropositive (=1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32. Chi-square tests will be used to test the statistical significance among seroconversion rates across study arms.	up to 3 months