VaccinationPhase 4NCT04054492

To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

A Phase 4 study testing Sabin-IPV+bOPV+bOPV, Sabin-IPV+Sabin-IPV+bOPV and Sabin-IPV+Sabin-IPV+Sabin-IPV in people with Vaccination and Reaction - Vaccine, run by China National Biotec Group Company Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV. Read more about this study

Who is it for?: Ages 60 to 89 daysHealthy volunteers can take part
Conditions the study is for: Vaccination, Reaction - Vaccine
What is being tested?: Sabin-IPV+bOPV+bOPV, Sabin-IPV+Sabin-IPV+bOPV and Sabin-IPV+Sabin-IPV+Sabin-IPV
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 604 participants
Where: 1 siteChina
Study dates: 1 Mar 2018to 12 Jun 2019
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 60 to 89 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

subjects aged from 60 days to 89 days 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 did not receive any vaccination within 14 days;
axillary temperature ≤37.0℃

Who cannot join

allergic to any ingredient of vaccine or with allergy history to any vaccine;
acute febrile disease or infectious disease;
serious chronic diseases;
any other factor that makes the investigator determines the subject is unsuitable for this study;

Trial locations and contacts

1 site in 1 country.

China1 site

Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
Hohhot, Inner Mongolia, 010031

Other trials in China

About this study

Official title: A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.

Read the detailed description

A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups.

Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.

Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.

Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.

Conditions: Vaccination, Reaction - Vaccine
Being tested: Sabin-IPV+bOPV+bOPV, Sabin-IPV+Sabin-IPV+bOPV, Sabin-IPV+Sabin-IPV+Sabin-IPV

What participants receive

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

Sabin-IPV+bOPV+bOPVBiological
202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
Sabin-IPV+Sabin-IPV+bOPVBiological
197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
Sabin-IPV+Sabin-IPV+Sabin-IPVBiological
205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively

Study groups in NCT04054492
Study group	Role	What they receive
sIPV+bOPV+bOPV	Experimental	202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively Receives: Biological: Sabin-IPV+bOPV+bOPV
sIPV+sIPV+bOPV	Active comparator	197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively Receives: Biological: Sabin-IPV+Sabin-IPV+bOPV
sIPV+sIPV+sIPV	Active comparator	205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively Receives: Biological: Sabin-IPV+Sabin-IPV+Sabin-IPV

What is being measured

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

Seroconversion rates at both baseline and 30 days after the 3rd vaccination
Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination
Measured: 4 months

Secondary outcomes (1)

Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination
Measure neutralizing antibody titers against poliovirus type I, II and III at both baseline and 30 days after the 3rd vaccination
Measured: 4 months

Timeline

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

1 Mar 201812 Jun 2019

First posted13 Aug 2019
Study start1 Mar 2018
Primary completion25 Jan 2019
Study completion12 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VaccinationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 604 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04054492
Sponsor's protocol ID: sIPV-2018XG-02
Status last verified: Aug 2019
First submitted: 9 Aug 2019
Last updated: 13 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yan S, Chen H, Zhang Z, Chang S, Xiao Y, Luo L, Zhang Z, Sun L, Chen X, Yang Y, Shi X, Guo Y, Sun Y, Li H, Li N, Han S, Ma M, Yang X. Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China. Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31.
PubMed 32747216

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
ClinicalTrials.gov ID: NCT04054492
Acronym / sponsor ID: sIPV-2018XG-02
Conditions: Vaccination, Reaction - Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 604 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Inner Mongolia Autonomous Region Center for Diseases Prevention and Control, Shaanxi Provincial Center for Disease Control and Prevention, Hebei Provincial Center for Diseases Prevention and Control, Peking University
Study start: 1 Mar 2018 (actual)
Primary completion: 25 Jan 2019 (actual)
Study completion: 12 Jun 2019 (actual)
First posted: 13 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.

Detailed description

Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.

Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.

Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
sIPV+bOPV+bOPV	Experimental	Biological: Sabin-IPV+bOPV+bOPV202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
sIPV+sIPV+bOPV	Active comparator	Biological: Sabin-IPV+Sabin-IPV+bOPV197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
sIPV+sIPV+sIPV	Active comparator	Biological: Sabin-IPV+Sabin-IPV+Sabin-IPV205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively

Who may qualify

Ages: 60 to 89 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

subjects aged from 60 days to 89 days 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 did not receive any vaccination within 14 days;
axillary temperature ≤37.0℃

Key exclusion criteria (4 listed)

allergic to any ingredient of vaccine or with allergy history to any vaccine;
acute febrile disease or infectious disease;
serious chronic diseases;
any other factor that makes the investigator determines the subject is unsuitable for this study;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sabin-IPV+bOPV+bOPV202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively	Biological	sIPV+bOPV+bOPV
Sabin-IPV+Sabin-IPV+bOPV197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively	Biological	sIPV+sIPV+bOPV
Sabin-IPV+Sabin-IPV+Sabin-IPV205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively	Biological	sIPV+sIPV+sIPV

Primary outcome

Seroconversion rates at both baseline and 30 days after the 3rd vaccination
Time frame: 4 months
Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination

1 secondary outcome

Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination
Time frame: 4 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
Derived from this study: PubMed 32747216Yan S, Chen H, Zhang Z, Chang S, Xiao Y, Luo L, Zhang Z, Sun L, Chen X, Yang Y, Shi X, Guo Y, Sun Y, Li H, Li N, Han S, Ma M, Yang X. Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China. Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shaohong Yan principal investigator

Inner Mongolia Autonomous Region Center for Diseases Prevention and Control

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rates at both baseline and 30 days after the 3rd vaccination (time frame: 4 months). 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 NCT04054492, 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 13 Aug 2019.