Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

Active, not recruiting

• Conditions: Polio
• Interventions: Other: no intervention

• Registration Number: NCT06058429
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-16
• Primary Completion: 2023-09-07
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 233

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2-3 months infants group	no intervention	Subjects in this group had recieved three dose of sIPV as primay immunization, and about half of them recieved DTaP simultaneously.
18 months children group	no intervention	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.

Primary Outcome Measures

Name	Time	Method
seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children	1 month
Antibody positivity rate of sIPV vaccine after primary immunization in infants	1 month
Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children	1 month

Secondary Outcome Measures

Name	Time	Method
GMT of antibodies against different enteroviruses	1 month
GMT of sIPV vaccine after primary immunization in infants	1 month
GMT of sIPV after booster immunization with sIPV vaccine in young children	1 month

Trial Locations

Locations (1)

Jiangxi Center for Disease Control and Prevention; 🇨🇳 Nanchang, Jiangxi, China