PolioPhase 4NCT06920069
Study of Concomitant Administration of the sIPV and DTaP or MMR
A Phase 4 study testing sIPV, DTaP and bOPV 1,3 in people with Polio and Diphteria, Tetanus and Pertussis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Polio, Diphteria, Tetanus and Pertussis, MMR Vaccine
- What is being tested?
- sIPV, DTaP and bOPV 1,3
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,640 participants
- Where
- 9 sitesChina
- Study dates
- 15 May 2025to 15 Jun 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites
Lufeng Center for Disease Control and Prevenion
Chuxiong, Yunnan, 651299
Jian Li, 0878-4125708 ext. +86, lfcdcmy@126.com
Yuanmou Center for Disease Control and Prevention
Chuxiong, Yunnan, 651300
Wanqun Yang, 0878-6017038 ext. +86, ymxywq@126.com
Wuding Center for Disease Control and Prevention
Chuxiong, Yunnan, 651600
Songqing Chen, 0878-8712104 ext. +86, wdcdcymbgs@126.com
Yaoan Center for Disease Control and Prevention
Chuxiong, Yunnan, 675300
Lan Chen, 0878-5712263 ext. +86, yajkmyb@163.com
Lancang Center for Disease Control and Prevention
Puer, Yunnan, 665699
Yunfeng Xu, 0879-7222429 ext. +86, lcxymyj@163.com
Yanshan Center for Disease Control and Prevention
Wenshan, Yunnan, 663100
Yongxian Zha, 0876-3122302 ext. +86, 2209221135@qq.com
Qiubei Center for Disease Control and Prevention
Wenshan, Yunnan, 663200
Shuzuo Tan, 0876-4122173 ext. +86, 343311329@qq.com
Guangnan Center for Disease Control and Prevention
Wenshan, Yunnan, 663300
Tingzhao Lin, 13688726934 ext. +86, 535224629@qq.com
Mile Center for Disease Control and Prevention
Yisa, Yunnan, 652399
Pinjing Chen, 18988262848 ext. +86, 2075499584@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Polio, Diphteria, Tetanus and Pertussis, MMR Vaccine
- Being tested
- sIPV, DTaP, bOPV 1,3, MMR Vaccine
- Medical subject headings
- Poliomyelitis, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPVBiological
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaPBiological
Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
bOPV 1,3Biological
Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose
MMR VaccineBiological
Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: sIPV; Biological: DTaP; Biological: bOPV 1,3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between baseline and day 30 after basic vaccination
Secondary outcomes (58)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Antibody assay will be performed using the ELISA method
Measured: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Antibody assay will be performed using the ELISA method
Measured: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Antibody assay will be performed using the ELISA method
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-measles virus antibody
Antibody assay will be performed using the ELISA method.
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-rubella virus antibody
Antibody assay will be performed using the ELISA method.
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-mumps virus antibody
Antibody assay will be performed using the ELISA method.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between baseline and day 30 after vaccination
Safety index-incidence of adverse events
Incidence of adverse events after vaccination
Measured: 0-30 minutes after vaccination
Safety index-incidence of solicitied adverse events
Incidence of solicited local and systematic adverse events after vaccination
Measured: Day 0-7 or Day 0-14 after vaccination
Safety index-incidence of unsolicitied adverse events
Incidence of unsolicited adverse events after vaccination
Measured: Day 0-30 after vaccination
Safety index-incidence of serious adverse events
Incidence of serious adverse events
Measured: From the beginning of the vaccination up to 6 months after vaccination completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion15 Jul 2030 (estimated)
- Study completion15 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolioStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Zheng, Principal investigator, Yunnan Provical Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920069
- Sponsor's protocol ID
- sIPV-401
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06920069
- Acronym / sponsor ID
- sIPV-401
- Conditions
- Polio, Diphteria, Tetanus and Pertussis, MMR Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,640 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 Jul 2030 (estimated)
- Study completion
- 15 Jun 2031 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sIPV + DTaP (concomitant vaccination cohort) | Experimental | Biological: sIPV, Biological: DTaPsIPV at 2,3,4 and 18 months of age, DTaP at 2,4,6 and 18 months of age |
| sIPV/bOPV + DTaP (concomitant vaccination cohort) | Experimental | Biological: sIPV, Biological: DTaP, Biological: bOPV 1,3sIPV 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 |
| sIPV + DTaP + MMR (systematic interval-based vaccination cohort) | Experimental | Biological: sIPV, Biological: DTaP, Biological: MMR VaccinesIPV 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 |
| sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort) | Experimental | Biological: sIPV, Biological: DTaP, Biological: bOPV 1,3sIPV 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 |
Who may qualify
- Ages
- 2 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sIPVSabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose | Biological | 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) |
| DTaPAdsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose | Biological | 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 1,3Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose | Biological | sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort), sIPV/bOPV + DTaP (concomitant vaccination cohort) |
| MMR VaccineMeasles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose | Biological | sIPV + DTaP + MMR (systematic interval-based vaccination cohort) |
Primary outcome
Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after basic vaccination
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
Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after basic vaccination
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
Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after basic vaccination
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
Immunogenicity index-seroconversion rate of anti-DT antibody
Time frame: Between baseline and day 30 after basic vaccination
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.
Immunogenicity index-seroconversion rate of anti-TT antibody
Time frame: Between baseline and day 30 after basic vaccination
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.
Immunogenicity index-seroconversion rate of anti-PT antibody
Time frame: Between baseline and day 30 after basic vaccination
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.
Immunogenicity index-seroconversion rate of anti-FHA antibody
Time frame: Between baseline and day 30 after basic vaccination
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.
58 secondary outcomes
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-DT antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-DT antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-TT antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-TT antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-PT antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-PT antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-seropositive rate of anti-FHA antibody
Time frame: Day 30 after basic vaccination
Immunogenicity index-seropositive rate of anti-FHA antibody
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT
Time frame: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against DT
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Time frame: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against TT
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Time frame: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against PT
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Time frame: Day 30 after basic vaccination
Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA
Time frame: Day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT
Time frame: Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT
Time frame: Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT
Time frame: Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT
Time frame: Between baseline and day 30 after full vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT
Time frame: Between baseline and day 30 after basic vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT
Time frame: Between baseline and day 30 after full vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Zheng principal investigator
Yunnan Provical Center for Disease Control and Prevention
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sIPV, DTaP and bOPV 1,3 in people with Polio and Diphteria, Tetanus and Pertussis, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingsi Yang (0871-68334551 ext. +86, yjs@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody (time frame: Between baseline and day 30 after basic vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.