Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations

NCT07354269 | Recruiting Phase 4

• 1 other identifier: PRO-sIPV-4004
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical study is to compare the immunogenicity and safety of one dose of sIPV in adolescents or adults aged 7-50 years with that of three doses of DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (3)

• The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years

  SCR indicates seroconversion rate；nab indicates neutralizing antibody

  day 30 after the single dose vaccination

• The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 18-50 years

  SCR indicates seroconversion rate; nab indicates neutralizing antibody

  day 30 after the single dose vaccination

• The SCR of nab against three serotypes of polioviruses at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months

  SCR indicates seroconversion rates; nab indicates neutralizing antibody

  day 30 after the single dose vaccination

Secondary Outcomes (10)

• The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years

  0-30 days after vaccination

• The frequency of SAEs within 30 days after vaccination in participants aged 7-50 years

  0-30 days after vaccination

• The frequency of adverse reactions within 30 days after vaccination in infants

  0-30 days after vaccination

• The frequency of SAEs within 30 days after vaccination in infants

  0-30 days after vaccination

• The SPR of antibody against PT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months

  day 30 after three doses of vaccination

Study Arms (2)

sIPV group

EXPERIMENTAL

adolescents or adults aged 7-50 years

Biological: sIPV

DTaP-IPV-Hib group

ACTIVE COMPARATOR

infants aged 3 months old

Biological: DTaP-IPV-Hib

Interventions

sIPV BIOLOGICAL

one dose of sIPV administered via intramuscular injection

sIPV group

DTaP-IPV-Hib BIOLOGICAL

three doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old

DTaP-IPV-Hib group

Eligibility Criteria

• Age: 3 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
• Participants and/or their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign);
• Provide valid proof of identity;
• Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
• Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 3 months after vaccination with the study vaccine, and have no plans to donate sperm or eggs.

You may not qualify if:

• Known history of polio/polio infection.
• Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months).
• History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.
• Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
• Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).
• Premature birth (delivery before the 37th week of gestation) or low birth weight (birth weight \<2500g), or history of asphyxiation, or history of neurological damage (applies to infants aged 3 months).
• Severe congenital malformations, genetic defects, and malnutrition.
• Current or past history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding a history of febrile seizures\]) or psychiatric disorders, or family history of psychiatric disorders.
• Acute exacerbations of various acute or chronic diseases within the past 3 days, or known or suspected active infections.
• History of vaccination with any vaccine containing DTP, IPV, Hib components, or pneumococcal polysaccharide conjugate vaccine (applies to infants aged 3 months).
• Received immunosuppressive or other immunomodulatory treatment for ≥14 days within the past 6 months (≥20mg/day of prednisone for those ≥18 years old, ≥2mg/kg/day for those \<18 years old, or equivalent doses), cytotoxic treatment, or plans to receive such treatment during the study.
• Received immunoglobulin or other blood products within the past 6 months, or plans to receive such treatment during the study.
• Received other investigational drugs or vaccines within the past 30 days, or plans to receive such drugs or vaccines during the study.
• Received live attenuated vaccines, nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
• Known allergy to any component of the study vaccine (inactivated poliovirus, 199 medium, glycine, sodium chloride, potassium chloride, calcium chloride, magnesium phosphate, disodium phosphate, monosodium phosphate \[for adolescents and adults\]; inactivated poliovirus, diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous hemagglutinin, Haemophilus influenzae type b capsular polysaccharide, tetanus protein conjugate \[for infants aged 3 months\]).

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (3)

Longxi County Center for Disease Prevention and Control, Dingxi City

Dingxi, Gansu, China

RECRUITING

Chengguan District Center for Disease Prevention and Control, Lanzhou City

Lanzhou, Gansu, China

RECRUITING

Zhangye Center for Disease Prevention and Control

Zhangye, Gansu, China

RECRUITING

MeSH Terms

Conditions

Poliomyelitis

Interventions

diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine

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

Central Study Contacts

Xiaoshu Zhang

CONTACT

86-0931-8277391; zhxs000@126.com

Study Design

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

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: January 21, 2026
• Study Start: September 26, 2025
• Primary Completion: April 11, 2026
• Study Completion: May 2, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-04

Locations

CN (3)