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VaccinationPhase 4NCT04636827

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

A Phase 4 study testing sIPV+DTaP+HepA, sIPV and DTaP in people with Vaccination, run by China National Biotec Group Company Limited at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: 1. Group 1: sIPV + DTaP + HepA, 2. Group 2: sIPV only, 3. Group 3: DTaP only, 4. Read more about this study

Who is it for?
Ages 18 to 19 monthsHealthy volunteers can take part
Conditions the study is for
Vaccination
What is being tested?
sIPV+DTaP+HepA, sIPV and DTaP
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
3 sitesChina
Study dates
11 Nov 2020to Dec 2021
Phase
Phase 4
Are there results?
None posted in the registry

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 18 to 19 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04053010) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
  • Subjects aged 18-19 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 not been vaccinated with sIPV/DTaP/HepA at the age of 18-month-old yet;
  • No less than 14 days since the last dose of vaccination;
  • Axillary temperature ≤37.0℃.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Shaobai Zhang contact

+86-29-82231502

maolyzhang@163.com

China3 sites, 3 recruiting

  • Hebei Provincial Center for Disease Control and Prevention

    Shijiazhuang, Hebei, 050024

    Zhenguo Zhang, +86-311-86573434, hbepi@hotmail.com

    Recruiting

  • Shanxi Provincial Center for Disease Control and Prevention

    Taiyuan, Shanxi, 030012

    Shaoying Chang, +86-351-7553136, chshy007@163.com

    Recruiting

  • Shaanxi Provincial Center for Disease Control and Prevention

    Xi'an, Shaanxi, 710054

    Shaobai Zhang, +86-29-82211350, maolyzhang@163.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA)

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

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

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 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)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml).

Blood samples will be collected before vaccination and 30-40 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.

Conditions
Vaccination
Being tested
sIPV+DTaP+HepA, sIPV, DTaP, HepA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sIPV+DTaP+HepABiological

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

  • sIPVBiological

    sIPV at the age of 18 month old

  • DTaPBiological

    DTaP at the age of 18 month old

  • HepABiological

    HepA at the age of 18 month old

Study groups in NCT04636827
Study groupRoleWhat they receive
group 1 (sIPV+DTaP+HepA)Experimental150 subjects; simultaneously administration of sIPV+DTaP+HepA as booster immunization at the age of 18 months old, 0.5 ml each, respectively
Receives: Biological: sIPV+DTaP+HepA
group 2 (sIPV)Active comparator150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old
Receives: Biological: sIPV
group 3 (DTaP)Active comparator150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old
Receives: Biological: DTaP
group 4 (HepA)Active comparator150 subjects; vaccination of 0.5 ml HepA as booster immunization at the age of 18 months old
Receives: Biological: HepA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion rate (sIPV)

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

    Measured: Baseline (before vaccination) results

  2. Seroconversion rate (sIPV)

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

    Measured: Results obtained 30-40 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

    Measured: 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

    Measured: Results obtained 30-40 days after vaccination

  5. Seroconversion rate (HepA)

    determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects

    Measured: Baseline (before vaccination) results

  6. Seroconversion rate (HepA)

    determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects

    Measured: Results obtained 30-40 days after vaccination

  7. Geometric Mean Concentration (GMC) (sIPV)

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

    Measured: Baseline (before vaccination) results

  8. Geometric Mean Concentration (GMC) (sIPV)

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

    Measured: Results obtained 30-40 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

    Measured: 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

    Measured: Results obtained 30-40 days after vaccination

  11. Geometric Mean Concentration (GMC) (HepA)

    GMCs of anti-hepatitis A virus antibody of the subjects

    Measured: Baseline (before vaccination) results

  12. Geometric Mean Concentration (GMC) (HepA)

    GMCs of anti-hepatitis A virus antibody of the subjects

    Measured: Results obtained 30-40 days after vaccination

Secondary outcomes (1)

  1. Adverse Events Following Immunization (AEFI)

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

    Measured: 0-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start11 Nov 2020
  3. Primary completionAug 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636827
Sponsor's protocol ID
sIPV-DTaP-HepA-2020
Status last verified
Nov 2020
First submitted
16 Nov 2020
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu X, Han S, Wang H, Sun L, Zhang C, Chen X, Wang R, Chang S, Shi X, Chen H, Wang Y, Zhang D, Guo Y, Zhang S, Hu W. Immunogenicity and safety of co-administration of sabin-strain-based inactivated poliovirus vaccine, diphtheria-tetanus-acellular pertussis vaccine, and live attenuated hepatitis A vaccine in 18-month-old children: A multicenter randomized controlled non-inferiority trial in China. Vaccine. 2025 Nov 20;67:127891. doi: 10.1016/j.vaccine.2025.127891. Epub 2025 Oct 27.

    PubMed 41151164

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sIPV+DTaP+HepA, sIPV and DTaP in people with Vaccination, run by China National Biotec Group Company Limited at 3 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shaobai Zhang (+86-29-82231502, maolyzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate (sIPV) (time frame: Baseline (before vaccination) results). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04636827, which also lists 1 linked publication.

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 19 Nov 2020.

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