- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01056705
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV) (Sabin IPV)
The Phase Ⅱ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.
Oral Poliomyelitis Vaccine(OPV)was manufactured by Institute of Medical Biology, Chinese Academy of Medical Sciences.Trivalent OPV contains Polioviruses Type 1 6.0 log CCID Type 2 5.0 log Type 3 5.5log /0.1ml/per dose Inactivated Poliomyelitis Vaccine (Salk strains)was manufactured by Sanofi Pasteur DAg contents /0.5ml/per dose were Type 1 40 DU,Type 2 8DU,Type 3 32DU.
This is a randomized, blind phase 2 clinical trial. Total 500 infants (ages 60 days to 90 days) were selected , randomized to five groups(each group n=100) Sabin IPV formulations A,B,C,OPV ,Salk IPV were separately given to each group with three doses one month apart respectively.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Guangxi
-
Pingle county, Guangxi, China, 542400
- Pingle Center for Disease Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females, age from 60 days to 90 days;
- Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
- Axillary temperature ≤37℃.
Exclusion Criteria:
- Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
- Low platelet or bleeding disorder do not allow vaccination into the muscle;
- Have damaged or lower immunological function;
- Received blood, plasma or immunoglobulin treatment since birth;
- Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
- Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Exclusion Criteria for doses 2 and 3
- Have serious anaphylaxis or high fever, convulsion during first dose;
- Have any circus of Exclusion Criteria after Eligible for study;
- Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
- Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
- Vaccinated with any other vaccine(except DTP);
- Stop observation determined by investigator owing to occurring serious adverse event;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: Experiment Infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections;
|
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
Other Names:
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
Other Names:
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
Other Names:
|
Experimental: Cohort 2: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections;
|
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
Other Names:
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
Other Names:
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
Other Names:
|
Experimental: Cohort 3: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections;
|
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
Other Names:
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections, one month apart.
Other Names:
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections, one month apart.
Other Names:
|
Experimental: Cohort 4: Experiment infants
Biological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml
oral;
|
Oral Poliomyelitis Vaccine (OPV).3x0.5mloral,
one month apart.
Other Names:
|
Experimental: Cohort 5: Experiment infants
Biological: Inactivated Poliomyelitis Vaccine (Salk strains).
3x0.5ml intramuscular injections;
|
3x0.5ml intramuscular injections, one month apart.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants .
Time Frame: one year
|
one year
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Sun M, Li C, Xu W, Liao G, Li R, Zhou J, Li Y, Cai W, Yan D, Che Y, Ying Z, Wang J, Yang H, Ma Y, Ma L, Ji G, Shi L, Jiang S, Li Q. Immune Serum From Sabin Inactivated Poliovirus Vaccine Immunization Neutralizes Multiple Individual Wild and Vaccine-Derived Polioviruses. Clin Infect Dis. 2017 May 15;64(10):1317-1325. doi: 10.1093/cid/cix110. Erratum In: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433.
- Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis. 2012 Jan 15;205(2):237-43. doi: 10.1093/infdis/jir723. Epub 2011 Dec 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Neuromuscular Diseases
- Central Nervous System Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Myelitis
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- imbcams-02
- SFDA2007L02021 (OTHER: China state food and drug adminstration)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Poliomyelitis
-
Uniformed Services University of the Health SciencesUnknown
-
GlaxoSmithKlineCompletedPoliomyelitis | Poliomyelitis VaccinesChina
-
University Hospital, MontpellierCompletedPoliomyelitis SequelaeFrance
-
University Hospital, MontpellierCompletedPost-Poliomyélitis SyndromFrance
-
International Centre for Diarrhoeal Disease Research...Centers for Disease Control and Prevention; Government of BangladeshNot yet recruiting
-
Institut de Sante Parasport Connecte SynergiesAssistance Publique - Hôpitaux de ParisRecruiting
-
Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, BangladeshCompleted
-
Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, Bangladesh; World Health... and other collaboratorsEnrolling by invitation
-
Pierre Van DammeBill and Melinda Gates Foundation; Centers for Disease Control and Prevention; PA... and other collaboratorsCompleted
-
Sinovac Biotech Co., LtdCompleted
Clinical Trials on Inactivated Poliomyelitis Vaccine (Sabin strains)
-
Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and Prevention; National Institute for the...Completed
-
Cancer Institute and Hospital, Chinese Academy...Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control; National Institute for the Control of Pharmaceutical and Biological Products, ChinaCompleted
-
LG ChemCompletedPoliomyelitisPhilippines, Thailand
-
Institute of Medical Biology, Chinese Academy of...Shanghai Center for Disease Control and PreventionCompleted
-
Pauline VerdijkWorld Health OrganizationCompleted
-
TakedaTerminated
-
Pauline VerdijkWorld Health OrganizationCompleted
-
LG ChemNot yet recruitingHepatitis B | Pertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus Influenzae Type B Infection
-
Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, Bangladesh; World Health... and other collaboratorsEnrolling by invitation
-
GlaxoSmithKlineCompletedPoliomyelitisKorea, Republic of