Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06058429

Enrollment

233

Registered

2023-09-28

Start date

2023-08-16

Completion date

2023-12-31

Last updated

2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polio

Keywords

immunogenicity of sIPV, primary immunization, booster immunization, simulteneous immunization, serology of antibodies against enterovirus

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.

Interventions

OTHERno intervention

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 27 Months

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

Design outcomes

Primary

Measure	Time frame
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

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

Other

Measure	Time frame
Antibody positivity rate and GMC for pertussis, diphtheria and tetanus after full vaccination with DTaP vaccine in infants	1 month
Antibody positivity rate and GMT for measles, rubella, and mumps after full vaccination of MMR vaccine in young children	1 month
Antibody positivity rate and GMC of hepatitis A vaccine after full vaccination in young children	1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026