An Immunity Persistence Study of Sabin Inactivated Poliovirus Vaccine(Vero Cell) After Four Doses

NCT04989231 | Completed

• 1 other identifier: PRO-sIPV-3003
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open and observational follow-up clinical trial based on the previous Phase III clinical trial of Sabin Inactivated Poliovirus Vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to evaluate the immunity persistence of sIPV in infants after 4 doses of vaccination.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

• All of participants with seroconversion rates of the neutralizing antibody of each group at the observation point wich at the age of 4 years (48 to 54 months) will be assessed

  About 3.0ml of venous blood will be collected from all of the subjects at the age of 4 years (48 to 54 months) and all of the participants with seroconversion rates of the neutralizing antibody at the observation point wich at the age of 4 years (48 to 54 months) will be compared to evaluate the immunity persistence of SIPV.

  At the age of 4 years (48 to 54 months) after the vaccination of the experimental vaccine or control vaccine

• All of participants with seroconversion rates of the neutralizing antibody of each group at the observation point wich in 5 years (78 to 84 months) after the last vaccination will be assessed

  About 3.0ml of venous blood will be collected from all of the subjects in 5 years (78 to 84 months) after the last vaccination and all of the participants with seroconversion rates of the neutralizing antibody at the observation point which in 5 years (78 to 84 months) after the last vaccination will be compared to evaluate the immunity persistence of SIPV.

  In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine

Secondary Outcomes (2)

• All of participants with geometric mean titer (GMT) of each group at the observation point wich at the age of 4 years (48 to 54 months) will be assessed

  At the age of 4 years (48 to 54 months)

• All of participants with geometric mean titer (GMT) of each group at the observation point wich in 5 years (78 to 84 months) after the last vaccination will be assessed

  In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine

Study Arms (2)

Experimental Group

Subjects who have received 4 doses of the experimental vaccine (including subjects at the age of 4 years (48 to 54 months) and 5 years (78 to 84 months) after the last vaccination ) will be collected venous blood about 3.0ml.

Biological: Investigational sIPV

Control Group

Subjects who have received 4 doses of control vaccine (including subjects at the age of 4 years (48 to 54 months) and 5 years (78 to 84 months) after the last vaccination ) will be collected venous blood about 3.0ml.

Biological: Control IPV

Interventions

Investigational sIPV BIOLOGICAL

Three intramuscular injections of the investigational vaccine (0.5 ml) at 0 month ,1 month and 2 months respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months

Experimental Group

Control IPV BIOLOGICAL

Three intramuscular injections of the control vaccine (0.5 ml) at 0 month ,1 month and 2 months respectively;Single intramuscular injection of the control vaccine (0.5ml) at 18 months

Control Group

Eligibility Criteria

• Age: 48 Months - 84 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

A total of at least 450 subjects will be enrolled, subjects should meet the inclusion criteria :Subjects who have received 4 doses of experimental vaccine or control vaccine in phase Ⅲ clinical trials and subjects should not meet the exclusion criteria:history of vaccination of other vaccine with poliovirus antigenic components except that of phaseⅢ clinical trial.

You may qualify if:

• Subjects who have received 4 doses of experimental vaccine or control vaccine in phase Ⅲ clinical trials

You may not qualify if:

• History of vaccination of other vaccine with poliovirus antigenic components except that of phaseⅢ clinical trial.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Pizhou county Center for Disease Control and Prevention

Pizhou, Jiangsu, 210009, China

Location

Related Publications (1)

• Chu K, Li Y, Yu D, Song Y, Liu S, Xue F, Shan Y, Meng W, Pan H. Immunogenicity and immune persistence in 4-year-old children completing four doses of Sabin strain or wild strain inactivated poliovirus vaccine: A phase IV, open-labeled, parallel-controlled observational study. Vaccine. 2023 May 22;41(22):3467-3471. doi: 10.1016/j.vaccine.2023.03.012. Epub 2023 Apr 29.

  PMID: 37127526 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The serum samples of this study will be only used for neutralizing antibody detection to evaluate immune persistence, and the use of other studies requires the consent of the subject's guardian and the approval of the ethics committee. Except for the serum submitted for testing, the remaining serum will be stored at the study site until the end of the study, and will be handed over to the sponsor for destruction according to the established SOP.

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Hongxing Pan, Master

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 4, 2021
• Study Start: September 9, 2021
• Primary Completion: December 25, 2022
• Study Completion: December 25, 2022
• Last Updated: January 12, 2023

Record last verified: 2021-10

Locations

CN (1)