The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)
IPV
The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
2 other identifiers
interventional
1,200
1 country
2
Brief Summary
Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ 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_3
Started Jan 2012
Typical duration for phase_3
2 active sites
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, 2012
CompletedFirst Submitted
Initial submission to the registry
January 6, 2012
CompletedFirst Posted
Study publicly available on registry
January 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 11, 2023
October 1, 2023
3.7 years
January 6, 2012
October 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
fours year
Secondary Outcomes (2)
The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
One year
Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV
30-60 days after third dose immunization
Study Arms (2)
Cohort 1
EXPERIMENTALInactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.
Cohort 2:
EXPERIMENTALInactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.
Interventions
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml 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 (2)
Pingle Center for Disease Prevention and Control
Guilin, Guangxi, 530400, China
Bingyang Center for Disease Prevention and Control
Nanning, Guangxi, 530400, China
Related Publications (1)
Ma L, Ying Z, Cai W, Wang J, Zhou J, Yang H, Gao J, Zhao Z, Liu J, Ouyang S, Song S, Shen F, Zhao R, Xu L, Dai X, Wu Y, Li W, Li C, Liao G. Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study. EClinicalMedicine. 2023 Sep 14;64:102151. doi: 10.1016/j.eclinm.2023.102151. eCollection 2023 Oct.
PMID: 37745024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoyang Liao, PH.D
Institute of Medical Biology, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Yanping Li, MD
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
- PRINCIPAL INVESTIGATOR
Changgui Li, PHD
National Institute for the Control of Pharmaceutical and Biological Products, China
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2012
First Posted
January 16, 2012
Study Start
January 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 11, 2023
Record last verified: 2023-10