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NCT Number: NCT06920069

Study of Concomitant Administration of the sIPV and DTaP or MMR

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.

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Key information

Conditions

Polio Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Diphteria, Tetanus and Pertussis Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections MMR Vaccine Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

2 month–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lufeng Center for Disease Control and Prevenion, Chuxiong, Yunnan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sIPV

Biological

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

DTaP

Biological

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

bOPV 1,3

Biological

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

MMR Vaccine

Biological

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

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

    Time frame: Day 30 after basic vaccination

    Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8

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

    Time frame: Day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8

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

    Time frame: Day 30 after basic vaccination

    Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8

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

    Time frame: Day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8

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

    Time frame: Day 30 after basic vaccination

    Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8

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

    Time frame: Day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8

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

    Time frame: Day 30 after basic vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

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

    Time frame: Day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

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

    Time frame: Day 30 after basic vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

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

    Time frame: Day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

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

    Time frame: Day 30 after basic vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

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

    Time frame: Day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

  13. Immunogenicity index-geometric mean fold increase (GMFI) 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.

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

    Time frame: Between baseline and day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

  15. Immunogenicity index-geometric mean fold increase (GMFI) 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.

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

    Time frame: Between baseline and day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

  17. Immunogenicity index-geometric mean fold increase (GMFI) 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.

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

    Time frame: Between baseline and day 30 after full vaccination

    Neutralizing antibody assay will be performed using the neutralization method.

  19. Immunogenicity index-seropositive rate of anti-DT antibody

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.

  20. Immunogenicity index-seropositive rate of anti-DT antibody

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.

  21. Immunogenicity index-seropositive rate of anti-TT antibody

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.

  22. Immunogenicity index-seropositive rate of anti-TT antibody

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥0.1 IU/ml.

  23. Immunogenicity index-seropositive rate of anti-PT antibody

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.

  24. Immunogenicity index-seropositive rate of anti-PT antibody

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.

  25. Immunogenicity index-seropositive rate of anti-FHA antibody

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.

  26. Immunogenicity index-seropositive rate of anti-FHA antibody

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as the antibody concentration≥20 IU/ml.

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

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after basic vaccination

    Antibody assay will be performed using the ELISA method

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

    Time frame: Between baseline and day 30 after full vaccination

    Antibody assay will be performed using the ELISA method

  43. Immunogenicity index-seroconversion rate of anti-measles virus antibody

    Time frame: Between baseline and day 30 after vaccination

    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

  44. Immunogenicity index-seroconversion rate of anti-rubella virus antibody

    Time frame: Between baseline and day 30 after vaccination

    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

  45. Immunogenicity index-seroconversion rate of anti-mumps virus antibody

    Time frame: Between baseline and day 30 after vaccination

    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

  46. Immunogenicity index-seropositive rate of anti-measles virus antibody

    Time frame: Day 30 after vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as antibody concentration ≥200mIU/ml

  47. Immunogenicity index-seropositive rate of anti-rubella virus antibody

    Time frame: Day 30 after vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as antibody concentration ≥20IU/ml

  48. Immunogenicity index-seropositive rate of anti-mumps virus antibody

    Time frame: Day 30 after vaccination

    Antibody assay will be performed using the ELISA method. Seropositive will be defined as antibody concentration ≥100U/ml

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

    Time frame: Day 30 after vaccination

    Antibody assay will be performed using the ELISA method.

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

    Time frame: Day 30 after vaccination

    Antibody assay will be performed using the ELISA method.

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

    Time frame: Day 30 after vaccination

    Antibody assay will be performed using the ELISA method.

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

    Time frame: Between baseline and day 30 after vaccination

    Antibody assay will be performed using the ELISA method.

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

    Time frame: Between baseline and day 30 after vaccination

    Antibody assay will be performed using the ELISA method.

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

    Time frame: Between baseline and day 30 after vaccination

    Antibody assay will be performed using the ELISA method.

  55. Safety index-incidence of adverse events

    Time frame: 0-30 minutes after vaccination

    Incidence of adverse events after vaccination

  56. Safety index-incidence of solicitied adverse events

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

    Incidence of solicited local and systematic adverse events after vaccination

  57. Safety index-incidence of unsolicitied adverse events

    Time frame: Day 0-30 after vaccination

    Incidence of unsolicited adverse events after vaccination

  58. Safety index-incidence of serious adverse events

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

    Incidence of serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Jingsi Yang

CONTACT

[email protected]

0871-68334551 ext. +86

Sponsors and collaborators

Lead sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Apr 9, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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