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Status unknownNCT04638985Updated Dec 10, 2020

Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR

A Phase 4 interventional study of sIPV+DTaP+MMR and sIPV in Vaccine, sponsored by China National Biotec Group Company Limited. Status unknown at 3 sites in China. Open to participants aged 18 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-10.

Sponsored by China National Biotec Group Company Limited · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Months to 18 Months
Sex
All
01

Study summary

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only.

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.

Read the detailed description

Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.

To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ MMR(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives MMR (0.5ml).

Blood samples will be collected before vaccination and 30 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

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Conditions studied

  • Vaccine
03

In context

Lead sponsor

China National Biotec Group Company Limited is the lead sponsor of 37 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
  • Subjects aged 18 months old at the date of recruitment;
  • With informed consent form (ICF) signed by parent(s) or guardian(s);
  • Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
  • Subjects have been vaccinated with a first dose of MMR, but have not been vaccinated with the 2nd dose of MMR and the booster (4th) dose of sIPV and DTaP;
  • No less than 14 days since the last dose of vaccination;
  • Axillary temperature ≤37.0℃.

Exclusion criteria

Exclusion Criteria:

  • With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
  • Allergic to any ingredient of vaccine or with allergy history to any vaccine;
  • Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
  • Administration of immunoglobulins within 30 days prior to this study;
  • Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
  • With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
  • With any serious chronic illness, acute infectious diseases, or respiratory diseases;
  • With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
  • With any kind of infectious, purulent, or allergic skin diseases;
  • With any other factor that makes the investigator determines the subject is unsuitable for this study.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    group 1 (sIPV+DTaP+MMR)

    150 subjects; simultaneously administration of sIPV+DTaP+MMR as booster immunization at the age of 18 months old, 0.5 ml each, respectively

    Biological: sIPV+DTaP+MMR

  • Active comparator
    group 2 (sIPV)

    150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old

    Biological: sIPV

  • Active comparator
    group 3 (DTaP)

    150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old

    Biological: DTaP

  • Active comparator
    group 4 (MMR)

    150 subjects; vaccination of 0.5 ml MMR as booster immunization at the age of 18 months old

    Biological: MMR

Interventions

  • BiologicalsIPV+DTaP+MMR

    sIPV+DTaP+MMR at the age of 18 month old

  • BiologicalsIPV

    sIPV at the age of 18 month old

  • BiologicalDTaP

    DTaP at the age of 18 month old

  • BiologicalMMR

    MMR at the age of 18 month old

06

What researchers measure

Primary outcomes

  1. Seroconversion rate (sIPV)

    determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects

    Time frame: Baseline (before vaccination) results

  2. Seroconversion rate (sIPV)

    determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects

    Time frame: Results obtained 30 days after vaccination

  3. Seroconversion rate (DTaP)

    determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects

    Time frame: Baseline (before vaccination) results

  4. Seroconversion rate (DTaP)

    determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects

    Time frame: Results obtained 30 days after vaccination

  5. Seroconversion rate (MMR)

    determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects

    Time frame: Baseline (before vaccination) results

  6. Seroconversion rate (MMR)

    determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects

    Time frame: Results obtained 30 days after vaccination

  7. Geometric Mean Concentration (GMC) (sIPV)

    GMCs of poliovirus type I, II and III of the subjects

    Time frame: Baseline (before vaccination) results

  8. Geometric Mean Concentration (GMC) (sIPV)

    GMCs of poliovirus type I, II and III of the subjects

    Time frame: Results obtained 30 days after vaccination

  9. Geometric Mean Concentration (GMC) (DTaP)

    GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects

    Time frame: Baseline (before vaccination) results

  10. Geometric Mean Concentration (GMC) (DTaP)

    GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects

    Time frame: Results obtained 30 days after vaccination

  11. Geometric Mean Concentration (GMC) (MMR)

    GMCs of measles, mumps, rubella antibodies of the subjects

    Time frame: Baseline (before vaccination) results

  12. Geometric Mean Concentration (GMC) (MMR)

    GMCs of measles, mumps, rubella antibodies of the subjects

    Time frame: Results obtained 30 days after vaccination

Secondary outcomes

  1. Adverse Events Following Immunization (AEFI)

    analyse the incidence of adverse events following immunization, both solicited and unsolicited

    Time frame: 0-6 months

07

Study locations

2 of 3 sites recruiting
  • Anhui Provincial Center for Disease Control and Prevention
    Hefei, Anhui 230601, China
    Recruiting
  • Jiangsu Province Centers for Disease Control and Prevention
    Nanjing, Jiangsu 210009, China
    Recruiting
  • Sichuan Center for Disease Control and Prevention
    Chengdu, Sichuan 610041, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04638985
Lead sponsor
China National Biotec Group Company Limited
Collaborators
Jiangsu Province Centers for Disease Control and Prevention, Anhui Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd., Chengdu Institute of Biological Products Co.,Ltd., Peking University, National Institutes for Food and Drug Control, China
Responsible party
Sponsor
First posted
Nov 20, 2020
Start date
Nov 13, 2020
Primary completion
Sep 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Dec 10, 2020

Study contacts

Fenyang Tang
Contact
tfyepi@163.com
+86-25-83759419
Fenyang Tang
principal investigator · Jiangsu Province Centers 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 ↗

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This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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