ClinicalTrials.gg
Sign In
Not yet recruitingNCT06920069Updated Apr 17, 2025

Study of Concomitant Administration of the sIPV and DTaP or MMR

A Phase 4 interventional study of sIPV and DTaP in Polio, Diphteria, Tetanus and Pertussis and MMR Vaccine, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences. Not yet recruiting at 9 sites in China. Open to participants aged 2 Months to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
2,640
Allocation
Randomized
Ages
2 Months to 2 Months
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Polio
  • Diphteria, Tetanus and Pertussis
  • MMR Vaccine
03

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's planned enrollment of 2,640 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences is the lead sponsor of 29 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 2 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • : 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

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 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 vaccine, or any other 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 therapy (such as long-term systemic 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,640 participants (estimated)

Study arms

  • 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 · Biological: DTaP

  • 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 · Biological: DTaP · Biological: bOPV 1,3

  • 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 · Biological: DTaP · Biological: MMR Vaccine

  • 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 · Biological: DTaP · Biological: bOPV 1,3

Interventions

  • BiologicalsIPV

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

  • BiologicalDTaP

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

  • BiologicalbOPV 1,3

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

  • BiologicalMMR Vaccine

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Between baseline and day 30 after basic vaccination

  2. 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

    Time frame: Between baseline and day 30 after basic vaccination

  3. 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

    Time frame: Between baseline and day 30 after basic vaccination

  4. 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.

    Time frame: Between baseline and day 30 after basic vaccination

  5. 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.

    Time frame: Between baseline and day 30 after basic vaccination

  6. 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.

    Time frame: Between baseline and day 30 after basic vaccination

  7. 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.

    Time frame: Between baseline and day 30 after basic vaccination

Secondary outcomes

  1. 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

    Time frame: Day 30 after basic vaccination

  2. 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

    Time frame: Day 30 after full vaccination

  3. 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

    Time frame: Day 30 after basic vaccination

  4. 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

    Time frame: Day 30 after full vaccination

  5. 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

    Time frame: Day 30 after basic vaccination

  6. 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

    Time frame: Day 30 after full vaccination

  7. Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Day 30 after basic vaccination

  8. Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Day 30 after full vaccination

  9. Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Day 30 after basic vaccination

  10. Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Day 30 after full vaccination

  11. Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Day 30 after basic vaccination

  12. Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Day 30 after full vaccination

  13. Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Between baseline and day 30 after basic vaccination

  14. Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Between baseline and day 30 after full vaccination

  15. Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Between baseline and day 30 after basic vaccination

  16. Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Between baseline and day 30 after full vaccination

  17. Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Between baseline and day 30 after basic vaccination

  18. Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody

    Neutralizing antibody assay will be performed using the neutralization method.

    Time frame: Between baseline and day 30 after full vaccination

  19. 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.

    Time frame: Day 30 after basic vaccination

  20. 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.

    Time frame: Day 30 after full vaccination

  21. 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.

    Time frame: Day 30 after basic vaccination

  22. 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.

    Time frame: Day 30 after full vaccination

  23. 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.

    Time frame: Day 30 after basic vaccination

  24. 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.

    Time frame: Day 30 after full vaccination

  25. 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.

    Time frame: Day 30 after basic vaccination

  26. 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.

    Time frame: Day 30 after full vaccination

  27. Immunogenicity index-geometric mean concentration (GMC) of antibody against DT

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after basic vaccination

  28. Immunogenicity index-geometric mean concentration (GMC) of antibody against DT

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after full vaccination

  29. Immunogenicity index-geometric mean concentration (GMC) of antibody against TT

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after basic vaccination

  30. Immunogenicity index-geometric mean concentration (GMC) of antibody against TT

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after full vaccination

  31. Immunogenicity index-geometric mean concentration (GMC) of antibody against PT

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after basic vaccination

  32. Immunogenicity index-geometric mean concentration (GMC) of antibody against PT

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after full vaccination

  33. Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after basic vaccination

  34. Immunogenicity index-geometric mean concentration (GMC) of antibody against FHA

    Antibody assay will be performed using the ELISA method

    Time frame: Day 30 after full vaccination

  35. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after basic vaccination

  36. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against DT

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after full vaccination

  37. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after basic vaccination

  38. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against TT

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after full vaccination

  39. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after basic vaccination

  40. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against PT

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after full vaccination

  41. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against FHA

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after basic vaccination

  42. Immunogenicity index-geometric mean fold increase (GMFI) of antibody against FHA

    Antibody assay will be performed using the ELISA method

    Time frame: Between baseline and day 30 after full vaccination

  43. 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

    Time frame: Between baseline and day 30 after vaccination

  44. 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

    Time frame: Between baseline and day 30 after vaccination

  45. 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

    Time frame: Between baseline and day 30 after vaccination

  46. 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

    Time frame: Day 30 after vaccination

  47. 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

    Time frame: Day 30 after vaccination

  48. 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

    Time frame: Day 30 after vaccination

  49. Immunogenicity index-geometric mean concentration (GMC) of anti-measles virus antibody

    Antibody assay will be performed using the ELISA method.

    Time frame: Day 30 after vaccination

  50. Immunogenicity index-geometric mean concentration (GMC) of anti-rubella virus antibody

    Antibody assay will be performed using the ELISA method.

    Time frame: Day 30 after vaccination

  51. Immunogenicity index-geometric mean concentration (GMC) of anti-mumps virus antibody

    Antibody assay will be performed using the ELISA method.

    Time frame: Day 30 after vaccination

  52. Immunogenicity index-geometric mean fold increase (GMFI) of anti-measles virus antibody

    Antibody assay will be performed using the ELISA method.

    Time frame: Between baseline and day 30 after vaccination

  53. Immunogenicity index-geometric mean fold increase (GMFI) of anti-rubella virus antibody

    Antibody assay will be performed using the ELISA method.

    Time frame: Between baseline and day 30 after vaccination

  54. Immunogenicity index-geometric mean fold increase (GMFI) of anti-mumps virus antibody

    Antibody assay will be performed using the ELISA method.

    Time frame: Between baseline and day 30 after vaccination

  55. Safety index-incidence of adverse events

    Incidence of adverse events after vaccination

    Time frame: 0-30 minutes after vaccination

  56. Safety index-incidence of solicitied adverse events

    Incidence of solicited local and systematic adverse events after vaccination

    Time frame: Day 0-7 or Day 0-14 after vaccination

  57. Safety index-incidence of unsolicitied adverse events

    Incidence of unsolicited adverse events after vaccination

    Time frame: Day 0-30 after vaccination

  58. Safety index-incidence of serious adverse events

    Incidence of serious adverse events

    Time frame: From the beginning of the vaccination up to 6 months after vaccination completed

07

Study locations

9 sites
  • Lufeng Center for Disease Control and Prevenion
    Chuxiong, Yunnan 651299, China
  • Yuanmou Center for Disease Control and Prevention
    Chuxiong, Yunnan 651300, China
  • Wuding Center for Disease Control and Prevention
    Chuxiong, Yunnan 651600, China
  • Yaoan Center for Disease Control and Prevention
    Chuxiong, Yunnan 675300, China
  • Mile Center for Disease Control and Prevention
    Honghe, Yunnan 652399, China
  • Lancang Center for Disease Control and Prevention
    Puer, Yunnan 665699, China
  • Yanshan Center for Disease Control and Prevention
    Wenshan, Yunnan 663100, China
  • Qiubei Center for Disease Control and Prevention
    Wenshan, Yunnan 663200, China
  • Guangnan Center for Disease Control and Prevention
    Wenshan, Yunnan 663300, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Jul 2030, 62 months later.

Of 30 phase 4 interventional studies under Poliomyelitis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's planned 62 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2025
First posted
Apr 9, 2025
StartEst.
May 15, 2025
Primary completionEst.
Jul 15, 2030
CompletionEst.
Jun 15, 2031
Last update
Apr 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06920069
Lead sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Responsible party
Sponsor
First posted
Apr 9, 2025
Start date
May 15, 2025 (estimated)
Primary completion
Jul 15, 2030 (estimated)
Completion
Jun 15, 2031 (estimated)
Last update
Apr 17, 2025

Study contacts

Jingsi Yang
Contact
yjs@imbcams.com.cn
0871-68334551 ext. +86
Yan Zheng
principal investigator · Yunnan Provical Center for Disease Control and Prevention

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Poliovirus Vaccine, Inactivated

Other studies in this condition

Poliomyelitis →

Other studies from this sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Start the discussion