Study of Concomitant Administration of the sIPV and DTaP or MMR

Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Adsorbed Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine or Measles, Mumps and Rubella Combined Live-attenuated Vaccine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polio; Diphteria, Tetanus and Pertussis; MMR Vaccine
• Intervention / Treatment: Biological: sIPV; Biological: DTaP; Biological: bOPV 1,3; Biological: MMR Vaccine

Detailed Description

This is a randomized, open-labeled, parallel phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR. 2640 participants aged 2 months will be randomly assigned to 4 cohorts in a ratio of 1:1:1:1. [Cohort A] 660 infants will take administration of sIPV at 2, 3, 4, 18 months of age and DTaP at 2, 4, 6, and 18 months of age. sIPV and DTaP at 2, 4, and 18 months of age will be taken concomitantly. [Cohort B] 660 infants will take administration of sIPV at 2, 3 months of age, bOPV at 4 months and 4 years of age, and DTaP at 2, 4, 6, 18 months of age. sIPV/bOPV at 2, 4 months of age will be taken concomitantly. [Cohort C] 660 infants will take administration of sIPV at 2, 3, 4, 18 months of age, DTaP at 2, 4, 6, and 18 months of age, and MMR at 18 months of age. DTaP will be taken 7 days after sIPV at 2, 4, 18 months of age. Half participants will take concomitant administration of sIPV and MMR at 18 months of age, and the rest will take them separately (MMR at 19 months of age). [Cohort D] 660 infants will take administration of sIPV at 2, 3 months of age, bOPV at 4 months and 4 years of age, and DTaP at 2, 4, 6, 18 months of age. DTaP will be taken 7 days after sIPV/bOPV at 2, 4 months of age.

For immunogenicity assessment, blood samples on Day 0 and Day 30 after basic immunization of each kind of investigational vaccine would be collected to evaluate the 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 for different groups.

For safety assessment, adverse events after each dose would be recorded through the diary and contact cards by participants' guardians to collect solicited or unsolicited AEs in periods of solicitation and nonsolicitation, respectively. From 31 days after the final dose to 6 months later, serious adverse events will be evaluated by the investigator via phone call or active reports by participants' guardians.

• Study Type: Interventional
• Enrollment (Estimated): 2640
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jingsi Yang; Phone Number: +86 0871-68334551; Email: yjs@imbcams.com.cn

Study Locations

• China
  • Yunnan
    • Chuxiong, Yunnan, China, 651299
      • Lufeng Center for Disease Control and Prevenion
      • Contact: Jian Li; Phone Number: +86 0878-4125708; Email: lfcdcmy@126.com
    • Chuxiong, Yunnan, China, 651600
      • Wuding Center for Disease Control and Prevention
      • Contact: Songqing Chen; Phone Number: +86 0878-8712104; Email: wdcdcymbgs@126.com
    • Chuxiong, Yunnan, China, 675300
      • Yaoan Center for Disease Control and Prevention
      • Contact: Lan Chen; Phone Number: +86 0878-5712263; Email: yajkmyb@163.com
    • Chuxiong, Yunnan, China, 651300
      • Yuanmou Center for Disease Control and Prevention
      • Contact: Wanqun Yang; Phone Number: +86 0878-6017038; Email: ymxywq@126.com
    • Honghe, Yunnan, China, 652399
      • Mile Center for Disease Control and Prevention
      • Contact: Pinjing Chen; Phone Number: +86 18988262848; Email: 2075499584@qq.com
    • Puer, Yunnan, China, 665699
      • Lancang Center for Disease Control and Prevention
      • Contact: Yunfeng Xu; Phone Number: +86 0879-7222429; Email: lcxymyj@163.com
    • Wenshan, Yunnan, China, 663100
      • Yanshan Center for Disease Control and Prevention
      • Contact: Yongxian Zha; Phone Number: +86 0876-3122302; Email: 2209221135@qq.com
    • Wenshan, Yunnan, China, 663200
      • Qiubei Center for Disease Control and Prevention
      • Contact: Shuzuo Tan; Phone Number: +86 0876-4122173; Email: 343311329@qq.com
    • Wenshan, Yunnan, China, 663300
      • Guangnan Center for Disease Control and Prevention
      • Contact: Tingzhao Lin; Phone Number: +86 13688726934; Email: 535224629@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sIPV + DTaP (concomitant vaccination cohort); sIPV at 2,3,4 and 18 months of age, DTaP at 2,4,6 and 18 months of age	Biological: sIPV; Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose; Biological: DTaP; Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
Experimental: sIPV/bOPV + DTaP (concomitant vaccination cohort); 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; Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose; Biological: DTaP; Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose; Biological: bOPV 1,3; Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose
Experimental: sIPV + DTaP + MMR (systematic interval-based vaccination cohort); 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; Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose; Biological: DTaP; Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose; Biological: MMR Vaccine; Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose
Experimental: sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort); 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; Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose; Biological: DTaP; Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose; Biological: bOPV 1,3; Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety index-incidence of adverse events	Incidence of adverse events after vaccination	0-30 minutes after vaccination
Safety index-incidence of serious adverse events	Incidence of serious adverse events	From the beginning of the vaccination up to 6 months after vaccination completed
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8	Day 30 after basic vaccination
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8	Day 30 after full vaccination
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8	Day 30 after basic vaccination
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8	Day 30 after full vaccination
Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8	Day 30 after basic vaccination
Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8	Day 30 after full vaccination
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Day 30 after basic vaccination
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Day 30 after full vaccination
Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Day 30 after basic vaccination
Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Day 30 after full vaccination
Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Day 30 after basic vaccination
Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody	Neutralizing antibody assay will be performed using the neutralization method.	Between baseline and day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-DT antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.	Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-DT antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.	Day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-TT antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.	Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-TT antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.	Day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-PT antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.	Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-PT antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.	Day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-FHA antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.	Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-FHA antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.	Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT	Antibody assay will be performed using the ELISA method	Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT	Antibody assay will be performed using the ELISA method	Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT	Antibody assay will be performed using the ELISA method	Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT	Antibody assay will be performed using the ELISA method	Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT	Antibody assay will be performed using the ELISA method	Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT	Antibody assay will be performed using the ELISA method	Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA	Antibody assay will be performed using the ELISA method	Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA	Antibody assay will be performed using the ELISA method	Day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against FHA	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against FHA	Antibody assay will be performed using the ELISA method	Between baseline and day 30 after full vaccination
Immunogenicity index-seroconversion rate of anti-measles virus antibody	Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (<200mIU/ml) to seropositive (≥200mIU/ml), or a ≥4-fold increase from baseline	Between baseline and day 30 after vaccination
Immunogenicity index-seroconversion rate of anti-rubella virus antibody	Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (<20IU/ml) to seropositive (≥20IU/ml), or a ≥4-fold increase from baseline	Between baseline and day 30 after vaccination
Immunogenicity index-seroconversion rate of anti-mumps virus antibody	Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (<100U/ml) to seropositive (≥100U/ml), or a ≥4-fold increase from baseline	Between baseline and day 30 after vaccination
Immunogenicity index-seropositive rate of anti-measles virus antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as antibody concentration ≥200mIU/ml	Day 30 after vaccination
Immunogenicity index-seropositive rate of anti-rubella virus antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as antibody concentration ≥20IU/ml	Day 30 after vaccination
Immunogenicity index-seropositive rate of anti-mumps virus antibody	Antibody assay will be performed using the ELISA method. Seropositive will be defined as antibody concentration ≥100U/ml	Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-measles virus antibody	Antibody assay will be performed using the ELISA method.	Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-rubella virus antibody	Antibody assay will be performed using the ELISA method.	Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-mumps virus antibody	Antibody assay will be performed using the ELISA method.	Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of anti-measles virus antibody	Antibody assay will be performed using the ELISA method.	Between baseline and day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of anti-rubella virus antibody	Antibody assay will be performed using the ELISA method.	Between baseline and day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of anti-mumps virus antibody	Antibody assay will be performed using the ELISA method.	Between baseline and day 30 after vaccination
Safety index-incidence of solicitied adverse events	Incidence of solicited local and systematic adverse events after vaccination	Day 0-7 or Day 0-14 after vaccination
Safety index-incidence of unsolicitied adverse events	Incidence of unsolicited adverse events after vaccination	Day 0-30 after vaccination

Collaborators and Investigators

• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Yan Zheng, Yunnan Provical Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2025
• Primary Completion (Estimated): July 15, 2030
• Study Completion (Estimated): June 15, 2031

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Bordetella Infections; Diphtheria; Tetanus; Whooping Cough
• Other Study ID Numbers: sIPV-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No