Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

NCT06058429 | Unknown

• 1 other identifier: PRO-sIPV-MA4001-1-JX
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Polio

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children

  1 month

Secondary Outcomes (3)

• 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

• GMT of antibodies against different enteroviruses

  1 month

Other Outcomes (3)

• Antibody positivity rate and GMC for pertussis, diphtheria and tetanus after full vaccination with DTaP vaccine in infants

  1 month

• Antibody positivity rate and GMC of hepatitis A vaccine after full vaccination in young children

  1 month

• Antibody positivity rate and GMT for measles, rubella, and mumps after full vaccination of MMR vaccine in young children

  1 month

Study Arms (2)

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.

Other: no intervention

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.

Other: no intervention

Interventions

no intervention OTHER

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

18 months children group; 2-3 months infants group

Eligibility Criteria

• Age: 2 Months - 27 Months
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead
• Jiangxi Center for Disease Control and Prevention: collaborator

Study Sites (1)

Jiangxi Center for Disease Control and Prevention

Nanchang, Jiangxi, 330029, China

Location

Related Publications (1)

• Guo S, Li Z, Zheng M, Wu F, Sun J, Tuo L, Li S, Li X, Wei L, Xia Z, Xie P, Chen X, Zhao Y, Gao Y, Yu D. Safety and 6-month immune persistence of inactivated poliovirus vaccine (Sabin strains) simultaneously administrated with other vaccines for primary and booster immunization in Jiangxi Province, China. Vaccine. 2024 Aug 30;42(21):126183. doi: 10.1016/j.vaccine.2024.126183. Epub 2024 Jul 31.

  PMID: 39088987 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: August 16, 2023
• Primary Completion: September 7, 2023
• Study Completion: December 31, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)