Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

Polio Clinical Trial

Official title:

Immunogenicity After Primary Immunization and Booster Immunization of Sabin Strain Inactivated Polio Vaccine (Vero Cells) in Infants and Young Children and Enterovirus Serological Monitoring Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06058429
• Other study ID #: PRO-sIPV-MA4001-1-JX
• Status: Active, not recruiting
• Start date: August 16, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 233
• Est. completion date: December 31, 2023
• Est. primary completion date: September 7, 2023
• Gender: All
• Age group: 2 Months to 27 Months

Eligibility

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

Related Conditions & MeSH terms

• Polio
• Poliomyelitis

Intervention

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

Locations

Country	Name	City	State
China	Jiangxi Center for Disease Control and Prevention	Nanchang	Jiangxi

Sponsors (2)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd	Jiangxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibody positivity rate and GMC for pertussis, diphtheria and tetanus after full vaccination with DTaP vaccine in infants		1 month
Other	Antibody positivity rate and GMC of hepatitis A vaccine after full vaccination in young children		1 month
Other	Antibody positivity rate and GMT for measles, rubella, and mumps after full vaccination of MMR vaccine in young children		1 month
Primary	Antibody positivity rate of sIPV vaccine after primary immunization in infants		1 month
Primary	Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children		1 month
Primary	seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children		1 month
Secondary	GMT of sIPV vaccine after primary immunization in infants		1 month
Secondary	GMT of sIPV after booster immunization with sIPV vaccine in young children		1 month
Secondary	GMT of antibodies against different enteroviruses		1 month