Status unknownNCT04053010Updated Aug 12, 2019

Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

A Phase 4 interventional study of Sabin-IPV and DTaP and Sabin-IPV in Vaccination, sponsored by China National Biotec Group Company Limited. Status unknown at 1 site in China. Open to participants aged 3 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-12.

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

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 702
Allocation: Randomized
Ages: 3 Months to 3 Months
Sex: All

Study summary

Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.

Read the detailed description

It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines.

To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

Conditions studied

Vaccination

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.

Who can participate

Ages eligible: 3 Months to 3 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

subjects aged 3 months old at the date of recruitment;
with informed consent signed by parent(s) or guardians;
parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;

Exclusion criteria

Exclusion Criteria:

subject who has 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;
have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
any serious chronic illness, acute infectious diseases, or respiratory diseases;
severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
any kind of infectious, purulent, or allergic skin diseases;
any other factor that makes the investigator determines the subject is unsuitable for this study.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 702 participants (estimated)

Study arms

Experimental
group 1
234 subjects; simultaneously administration of Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively
Biological: Sabin-IPV and DTaP
Active comparator
group 2
234 subjects; Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively
Biological: Sabin-IPV
Active comparator
group 3
234 subjects; DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively
Biological: DTaP

Interventions

BiologicalSabin-IPV and DTaP
Sabin-IPV +DTaP at the age of 3/4/5 months old respectively
BiologicalSabin-IPV
Sabin-IPV only at the age of 3/4/5 months old respectively
BiologicalDTaP
DTaP only at the age of 3/4/5 months old respectively

What researchers measure

Primary outcomes

Seroconversion rate I
determine the rate of positive seroconversion against poliovirus type I, II and III of the 3 groups
Time frame: 1 month after the 3rd dose
Seroconversion rate II
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the 3 groups
Time frame: 1 month after the 3rd dose
Neutralizing antibody titers I
Measure neutralizing antibody titers against poliovirus type I, II and III
Time frame: 1 month after the 3rd dose
Neutralizing antibody titers II
Measure neutralizing antibody titers against diphtheria, pertussis toxoid, pertussis filamentous hemagglutinin, and tetanic of the 3 groups
Time frame: 1 month after the 3rd dose

Secondary outcomes

safety outcomes
Adverse event following vaccinations
Time frame: 6 months

Study locations

1 of 1 sites recruiting

Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi 710054, China
- Shaobai ZHANG · Contact · maolyzhang@163.com · +86-29-82231502
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04053010
Lead sponsor: China National Biotec Group Company Limited
Collaborators: Wuhan Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd., Shaanxi Provincial Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention
Responsible party: Sponsor
First posted: Aug 12, 2019
Start date: Aug 10, 2019
Primary completion: Dec 31, 2019 (estimated)
Completion: May 30, 2020 (estimated)
Last update: Aug 12, 2019

Study contacts

Shaobai ZHANG

Contact

maolyzhang@163.com

+86-29-82231502

Haiping CHEN

Contact

chenhaiping@sinopharm.com

+86-10-84663393

Shaobai ZHANG

principal investigator · Shaanxi Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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