PolioPhase 4NCT03147560
Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
A Phase 4 study testing Sabin IPV+ bOPV+ bOPV, Sabin IPV + Sabin IPV + bOPV and Sabin IPV + Sabin IPV + Sabin IPV in people with Polio, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants. Read more about this study
- Who is it for?
- Ages 60 to 75 days
- Conditions the study is for
- Polio
- 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
- 528 participants
- Where
- 2 sitesChina
- Study dates
- 2 May 2017to 30 Dec 2017
- 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 75 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- Participant is aged ≥ 60 days to ≤ 75 days.
- Participant without preventive inoculation of polio vaccine and previous history of Polio.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Body temperature ≤ 37.5℃.
Who cannot join
- Known allergy to any constituent of the vaccine.
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
- Known bleeding disorder.
- Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
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- Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
- An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial.
- Participation in any other intervention clinical trial.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chunan Center for Disease Control and Prevention
Hangzhou, Zhejiang
Longyou Center for Disease Control and Prevention
Quzhou, Zhejiang
About this study
The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.
- Conditions
- Polio
- Being tested
- Sabin IPV+ bOPV+ bOPV, Sabin IPV + Sabin IPV + bOPV, Sabin IPV + Sabin IPV + Sabin IPV
- Keywords
- Immunogenicity, Safety, Sabin IPV, bOPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabin IPV+ bOPV+ bOPVBiological
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Sabin IPV + Sabin IPV + bOPVBiological
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Sabin IPV + Sabin IPV + Sabin IPVBiological
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV. Receives: Biological: Sabin IPV+ bOPV+ bOPV |
| Group 2 | Experimental | The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV. Receives: Biological: Sabin IPV + Sabin IPV + bOPV |
| Group 3 | Experimental | The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV. 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 rate
any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.
Measured: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
Secondary outcomes (2)
safety: rate of adverse events
the rate of adverse events.
Measured: At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
neutralizing antibody titer
Measured: Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start2 May 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
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 PolioStudies 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
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- China National Biotec Group Company Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147560
- Sponsor's protocol ID
- ZJCDC20170508
- Status last verified
- Sep 2019
- First submitted
- 8 May 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He H, Wang Y, Deng X, Yue C, Tang X, Li Y, Liu Y, Yin Z, Zhang G, Chen Z, Xie S, Wen N, An Z, Chen Z, Wang H. Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial. Lancet Infect Dis. 2020 Sep;20(9):1071-1079. doi: 10.1016/S1473-3099(19)30738-8. Epub 2020 May 19.
PubMed 32442523
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
- ClinicalTrials.gov ID
- NCT03147560
- Acronym / sponsor ID
- ZJCDC20170508
- Conditions
- Polio
- Keywords
- Immunogenicity, Safety, Sabin IPV, bOPV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Collaborators
- China National Biotec Group Company Limited
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 10 May 2017 (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 different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Sabin IPV+ bOPV+ bOPVThe sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV. |
| Group 2 | Experimental | Biological: Sabin IPV + Sabin IPV + bOPVThe sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV. |
| Group 3 | Experimental | Biological: Sabin IPV + Sabin IPV + Sabin IPVThe sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV. |
Who may qualify
- Ages
- 60 to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- Participant is aged ≥ 60 days to ≤ 75 days.
- Participant without preventive inoculation of polio vaccine and previous history of Polio.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Body temperature ≤ 37.5℃.
Key exclusion criteria (10 listed)
- Known allergy to any constituent of the vaccine.
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
- Known bleeding disorder.
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+ bOPVGive 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose. | Biological | Group 1 |
| Sabin IPV + Sabin IPV + bOPVGive 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose. | Biological | Group 2 |
| Sabin IPV + Sabin IPV + Sabin IPVGive 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose. | Biological | Group 3 |
Primary outcome
seroconversion rate
Time frame: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.
2 secondary outcomes
safety: rate of adverse events
Time frame: At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
neutralizing antibody titer
Time frame: Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
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 12 Sep 2019.
- Derived from this study: PubMed 32442523He H, Wang Y, Deng X, Yue C, Tang X, Li Y, Liu Y, Yin Z, Zhang G, Chen Z, Xie S, Wen N, An Z, Chen Z, Wang H. Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial. Lancet Infect Dis. 2020 Sep;20(9):1071-1079. doi: 10.1016/S1473-3099(19)30738-8. Epub 2020 May 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sabin IPV+ bOPV+ bOPV, Sabin IPV + Sabin IPV + bOPV and Sabin IPV + Sabin IPV + Sabin IPV in people with Polio, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 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 5 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: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 rate (time frame: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.). 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 NCT03147560, 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 12 Sep 2019.