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
2 other identifiers
interventional
500
1 country
1
Brief Summary
Based on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Shorter than P25 for phase_2
1 active site
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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 2, 2016
July 1, 2016
10 months
January 25, 2010
July 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does on Healthy infants .
one year
Study Arms (5)
Cohort 1: Experiment Infants
EXPERIMENTALBiological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections;
Cohort 2: Experiment infants
EXPERIMENTALBiological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation B. 3x0.5ml intramuscular injections;
Cohort 3: Experiment infants
EXPERIMENTALBiological: Inactivated Poliomyelitis Vaccine (Sabin strains) formulation C. 3x0.5ml intramuscular injections;
Cohort 4: Experiment infants
EXPERIMENTALBiological: Oral Poliomyelitis Vaccine (OPV).3x0.1ml oral;
Cohort 5: Experiment infants
EXPERIMENTALBiological: Inactivated Poliomyelitis Vaccine (Salk strains). 3x0.5ml intramuscular injections;
Interventions
Inactivated Poliomyelitis Vaccine (Sabin strains) formulation A. 3x0.5ml intramuscular injections,one month apart.
Oral Poliomyelitis Vaccine (OPV).3x0.5mloral, one month apart.
3x0.5ml intramuscular injections, one month apart.
Eligibility Criteria
You may qualify if:
- 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℃.
You may not qualify if:
- 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.
- Have serious anaphylaxis or high fever, convulsion during first dose;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pingle Center for Disease Control and Prevention
Pingle County, Guangxi, 542400, China
Related Publications (2)
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.
PMID: 28419204DERIVEDLiao 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.
PMID: 22158682DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liao Guoyang, PHD
Institute of Medical Biology, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Li Rongcheng, MD
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- PRINCIPAL INVESTIGATOR
Li Changgui, PHD
National Institute for the Control of Pharmaceutical and Biological Products, China
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Biologicals No.5
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 26, 2010
Study Start
July 1, 2009
Primary Completion
May 1, 2010
Study Completion
August 1, 2010
Last Updated
August 2, 2016
Record last verified: 2016-07