Study of Concomitant Administration of the sIPV and DTaP or MMR

NCT06920069 | Not Yet Recruiting Phase 4

• 1 other identifier: sIPV-401
• Study Type: interventional
• Target: 2,640
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after basic immunization. Secondary immunogenicity endpoints include the seropositive rates, seroconversion rates, geometric mean titer/concentration (GMT/GMC), geometric mean fold increase (GMFI) of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies 30 days after full immunization. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.

Conditions

Polio; Diphteria, Tetanus and Pertussis; MMR Vaccine

Outcome Measures

Primary Outcomes (7)

• Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline

  Between baseline and day 30 after basic vaccination

• Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline

  Between baseline and day 30 after basic vaccination

• Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline

  Between baseline and day 30 after basic vaccination

• Immunogenicity index-seroconversion rate of anti-DT antibody

  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.

  Between baseline and day 30 after basic vaccination

• Immunogenicity index-seroconversion rate of anti-TT antibody

  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.

  Between baseline and day 30 after basic vaccination

• Immunogenicity index-seroconversion rate of anti-PT antibody

  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.

  Between baseline and day 30 after basic vaccination

• Immunogenicity index-seroconversion rate of anti-FHA antibody

  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<20 IU/ml) to seropositive (Antibody Concentration≥20 IU/ml), or a ≥4-fold increase from baseline.

  Between baseline and day 30 after basic vaccination

Secondary Outcomes (58)

• Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody

  Day 30 after basic vaccination

• Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody

  Day 30 after full vaccination

• Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody

  Day 30 after basic vaccination

• Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody

  Day 30 after full vaccination

• Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody

  Day 30 after basic vaccination

Study Arms (4)

sIPV + DTaP (concomitant vaccination cohort)

EXPERIMENTAL

sIPV at 2,3,4 and 18 months of age, DTaP at 2,4,6 and 18 months of age

Biological: sIPV; Biological: DTaP

sIPV/bOPV + DTaP (concomitant vaccination cohort)

EXPERIMENTAL

sIPV at 2,3 months of age and bOPV at 4 months and 4 years of age DTaP at 2, 4, 6 and 18 months of age

Biological: sIPV; Biological: DTaP; Biological: bOPV 1,3

sIPV + DTaP + MMR (systematic interval-based vaccination cohort)

EXPERIMENTAL

sIPV at 2,3,4 and 18 months of age DTaP at 2,4,6 and 18 months of age, 7 days after the administration of sIPV MMR at 18 months of age, randomly assigned in the concomitant administration with sIPV or 1 month after the administration of DTaP

Biological: sIPV; Biological: DTaP; Biological: MMR Vaccine

sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort)

EXPERIMENTAL

sIPV at 2,3 months of age, bOPV at 4 months and 4 years of age DTaP at 2,4,6 and 18 months of age, 7 days after the administration of sIPV

Biological: sIPV; Biological: DTaP; Biological: bOPV 1,3

Interventions

sIPV BIOLOGICAL

Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose

sIPV + DTaP (concomitant vaccination cohort); sIPV + DTaP + MMR (systematic interval-based vaccination cohort); sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort); sIPV/bOPV + DTaP (concomitant vaccination cohort)

DTaP BIOLOGICAL

Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose

sIPV + DTaP (concomitant vaccination cohort); sIPV + DTaP + MMR (systematic interval-based vaccination cohort); sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort); sIPV/bOPV + DTaP (concomitant vaccination cohort)

bOPV 1,3 BIOLOGICAL

Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose

sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort); sIPV/bOPV + DTaP (concomitant vaccination cohort)

MMR Vaccine BIOLOGICAL

Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose

sIPV + DTaP + MMR (systematic interval-based vaccination cohort)

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age Requirement: Infants aged 2 months at the time of enrollment
• Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
• Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, and sign the informed consent form.
• Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.
• Birth Condition: Full-term at birth (gestational age ≥ 37 weeks and \< 42 weeks) and birth weight ≥ 2500g

You may not qualify if:

• Vaccination History: received vaccines containing diphtheria-tetanus-pertussis antigens, polio antigens, Hib conjugate vaccine, or 13-valent pneumococcal conjugate vaccine before enrollment.
• Those who had received blood transfusions or used blood products (except hepatitis B immunoglobulin) before enrollment.
• Recent Vaccination: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.
• Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days before enrollment, or have used antipyretic analgesics or antihistamines within 3 days.
• Allergic History: Volunteers who are allergic to any component of sIPV, bOPV, DTaP, or MMR, or who are allergic to kanamycin sulfate, kanamycin, or gentamicin sulfate, or those with an allergic constitution.
• Birth Condition: Severe neonatal diseases caused by abnormal delivery and other reasons, such as birth trauma, neonatal asphyxia, respiratory distress syndrome, neonatal intracranial hemorrhage, etc., or patients with clinically confirmed severe hyperbilirubinemia.
• Neurological and Mental Health: Volunteers with encephalopathy, convulsions, epilepsy, or other progressive neurological disorders, or those whose families have a history of genetic predisposition to convulsions or epilepsy, or a history of genetic predisposition to mental illness.
• History of Related Illness: Volunteers who have a history of poliomyelitis, pertussis, diphtheria, tetanus, measles, rubella, or mumps.
• Immune Therapy: Volunteers with immunodeficiency, weakened immune function, or those who have received immunosuppressive therapy (such as long-term systemic glucocorticoid treatment, but excluding local medications like inhalants or nasal sprays).
• Other Diseases: Volunteers with severe diseases, encompassing those in the cardiovascular system, blood and lymphatic systems, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, and bones, etc.
• Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead

Study Sites (9)

Lufeng Center for Disease Control and Prevenion

Chuxiong, Yunnan, 651299, China

Location

Yuanmou Center for Disease Control and Prevention

Chuxiong, Yunnan, 651300, China

Location

Wuding Center for Disease Control and Prevention

Chuxiong, Yunnan, 651600, China

Location

Yaoan Center for Disease Control and Prevention

Chuxiong, Yunnan, 675300, China

Location

Lancang Center for Disease Control and Prevention

Puer, Yunnan, 665699, China

Location

Yanshan Center for Disease Control and Prevention

Wenshan, Yunnan, 663100, China

Location

Qiubei Center for Disease Control and Prevention

Wenshan, Yunnan, 663200, China

Location

Guangnan Center for Disease Control and Prevention

Wenshan, Yunnan, 663300, China

Location

Mile Center for Disease Control and Prevention

Yisa, Yunnan, 652399, China

Location

MeSH Terms

Conditions

Poliomyelitis; Tetanus; Whooping Cough

Interventions

Measles-Mumps-Rubella 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; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• Yan Zheng

  Yunnan Provical Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingsi Yang

CONTACT

0871-68334551; yjs@imbcams.com.cn

Study Design

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

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): July 15, 2030
• Study Completion (Estimated): June 15, 2031
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)