NCT05432141

Brief Summary

The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

January 12, 2023

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 20, 2022

Last Update Submit

January 11, 2023

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine

    Incidence of adverse reactions within 0\~7 days after primary immunization of sIPV vaccine

    Within 0~7 days after primary immunization

Secondary Outcomes (8)

  • Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine

    Within 0~30 days after primary immunization

  • Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine

    Within 0~7 days after booster immunization

  • Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine

    Within 0~30 days after booster immunization

  • Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine

    Within 0-7 days after primary immunization combined with DTaP vaccine

  • Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine

    Within 0-30 days after primary immunization combined with DTaP vaccine

  • +3 more secondary outcomes

Study Arms (2)

Primary immunization group

EXPERIMENTAL

A total of 2000 infants aged 2-3 months will randomly assigned to two groups according to 1:1 using scratch cards: 1000 infants in the sIPV vaccine group and 1000 infants in the sIPV vaccine group plus DTaP vaccine group

Biological: sIPV vaccine /DTaP vaccine

Booster immunization group of sIPV vaccine

EXPERIMENTAL

A total of 1200 children aged 18 months will randomly assigned to four groups according to 2:2:1:1 using scratch cards: 400 in the sIPV booster group, 400 in the sIPV booster group plus inactivated hepatitis A vaccine simultaneously, 200 in the sIPV booster group plus MMR simultaneously, and 200 in the sIPV booster group plus attenuated hepatitis A vaccine.

Biological: sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine

Interventions

sIPV vaccine /DTaP vaccineBIOLOGICAL

All subjects received 3 doses of sIPV vaccines and 3 doses of DTaP vaccines. Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.

Primary immunization group
sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccineBIOLOGICAL

All subjects will receive 1 dose of sIPV and 2 doses of hepatitis A inactivated vaccine/or 1 dose of attenuated hepatitis A vaccine and 1 dose of MMR vaccine.Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.

Booster immunization group of sIPV vaccine

Eligibility Criteria

Age2 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants aged 2-3 months should be involved in primary immunization and they have not received Sabin strain inactivated polio vaccine (Vero Cell) in the past;
  • Children aged 18 months should be immunized with the first three doses of Sabin strain inactivated polio vaccine (Vero Cell) and they have not received any inactivated or attenuated live vaccines in the past 14 days;
  • The guardian agrees to sign the informed consent and voluntarily use the mobile APP to participate in the follow-up visits.

You may not qualify if:

  • Allergic to the active ingredient in the vaccine, any inactive ingredient, or substance used in the manufacturing process;
  • Allergic to this product or similar vaccines in the past;
  • Patients with severe chronic diseases or allergies;
  • Patients with fever or acute illness.
  • Any serious adverse events that are causally related to vaccination;
  • Severe anaphylaxis or hypersensitivity after vaccination (including hives and rashes within 30 minutes of vaccination);
  • Any confirmed or suspected autoimmune or immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
  • Acute or newly emerging chronic diseases occur at the time of vaccination;
  • Other reactions (including severe pain, severe swelling, severe limitation of movement, persistent high fever, severe headache, or other systemic or local reactions), as determined by the investigator;
  • Having an acute illness at the time of vaccination (acute illness is defined as moderate or severe illness with or without fever);
  • Axillary temperature \>37℃ during vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaoan Center for Disease Control and Prevention

Gao’an, Jiangxi, 330899, China

Location

Shangli County Center for Disease Control and Prevention

Pingxiang, Jiangxi, 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: 39088987DERIVED

MeSH Terms

Conditions

Poliomyelitis

Interventions

Diphtheria-Tetanus-acellular Pertussis VaccinesMeasles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Pertussis VaccineBacterial VaccinesVaccinesBiological ProductsComplex MixturesDiphtheria ToxoidToxoidsTetanus ToxoidVaccines, CombinedVaccines, AcellularVaccines, SubunitMeasles VaccineViral VaccinesMumps VaccineRubella Vaccine

Study Officials

  • Shicheng Guo, Master

    Jiangxi Provincial Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 27, 2022

Study Start

June 13, 2022

Primary Completion

September 13, 2022

Study Completion

December 13, 2022

Last Updated

January 12, 2023

Record last verified: 2022-06

Locations

CN(2)