Clinical trial NCT06058429: Immunogenicity of After Primary Immunization and Booster Immunization of sIPV
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Polio
Keywords: immunogenicity of sIPV
primary immunization
booster immunization
simulteneous immunization
serology of antibodies against enterovirus
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Jiangxi Center for Disease Control and Prevention
First posted: 2023-09-28
Enrollment: 233
Sex: ALL
Minimum age (years): 2
Maximum age (years): 27
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Antibody positivity rate of sIPV vaccine after primary immunization in infants
timeFrame: 1 month
measure: Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children
timeFrame: 1 month
measure: seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children
timeFrame: 1 month
Secondary outcomes:
measure: GMT of sIPV vaccine after primary immunization in infants
timeFrame: 1 month
measure: GMT of sIPV after booster immunization with sIPV vaccine in young children
timeFrame: 1 month
measure: GMT of antibodies against different enteroviruses
timeFrame: 1 month
Other outcomes:
measure: Antibody positivity rate and GMC for pertussis, diphtheria and tetanus after full vaccination with DTaP vaccine in infants
timeFrame: 1 month
measure: Antibody positivity rate and GMC of hepatitis A vaccine after full vaccination in young children
timeFrame: 1 month
measure: Antibody positivity rate and GMT for measles, rubella, and mumps after full vaccination of MMR vaccine in young children
timeFrame: 1 month
Locations:
city: Nanchang
country: China
facility: Jiangxi Center for Disease Control and Prevention
state: Jiangxi
Study officials:
References: