Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-16

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants

NCT05432141

Poliomyelitis

COMPLETED PHASE4

An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants

NCT03526978

Poliomyelitis

COMPLETED PHASE3

A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China.

NCT03597919

Poliomyelitis

COMPLETED PHASE4

A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China

NCT04614597

Poliomyelitis

COMPLETED

Safety of Sabin Inactivated Poliovirus Vaccine in Adults, Children and Infants and Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants

NCT05386810

Poliomyelitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polio

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2-3 months infants group

Subjects in this group had recieved three dose of sIPV as primay immunization, and about half of them recieved DTaP simultaneously.

no intervention

Intervention Type OTHER

This is an observation study after vaccination, no intervention will be used

18 months children group

Subjects in this group had recieved one dose of sIPV as booster immunization, and about half of them recieved MMR or hepatitis A vacine(live-attenuated or inactivated) simultaneously.

no intervention

Intervention Type OTHER

This is an observation study after vaccination, no intervention will be used

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

This is an observation study after vaccination, no intervention will be used

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participated in the previous study (ID: PRO-sIPV-MA4001-JX)
* Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination;
* There should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection;
* The guardian of subjects need to agree to sign the informed consent form.

Exclusion Criteria

* The interval between vaccination and blood collection is less than 1 month, or more than 9 months;
* Subjects were participating in other clinical studies of vaccines or drugs;
* Other conditions that make subjects unsuitable for participating in this study judged by investigator's

Minimum Eligible Age

2 Months

Maximum Eligible Age

27 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No