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NCT Number: NCT04989231

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

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.

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Key information

Conditions

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

Age range

48 month–84 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pizhou county Center for Disease Control and Prevention

Pizhou, Jiangsu, 210009, China

About this study

This study is an open and observational follow-up clinical trial based on the previous Phase III clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the immunity persistence of sIPV in infants after 4 doses of vaccination.A total of at least 450 subjects who have received 4 doses of the experimental vaccine or control vaccine will be enrolled,about 3.0ml of venous blood will be collected from each enrolled subject at the age of 4 years (48 to 54 months) and 5 years (78 to 84 months) after the last vaccination, respectively,and the serum will be separated for neutralizing antibody detection.The antibody levels of the experimental vaccine group and the control vaccine group will be compared to evaluate the immunity persistence of sIPV.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

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

    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.

  2. 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

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

    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.

Secondary outcomes

  1. 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

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

    All of participants with geometric mean titer (GMT) in experimental group and control group 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.

  2. 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

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

    All of participants with geometric mean titer (GMT) in experimental group and control group at the observation point wich in 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine will be compared to evaluate the immunity persistence of SIPV.

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Registry information

Official study title

An Open and Observational Phase Ⅳ Clinical Trial to Evaluate the Immunity Persistence of Sabin Inactivated Poliovirus Vaccine (Vero Cell) After Four Doses

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2021
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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