Polio and Post-Polio SyndromePhase 2NCT03902054
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.
A Phase 2 study testing Three-dose regimen of high dosage investigational sIPV, Three-dose regimen of medium dosage investigational sIPV and Three-dose regimen of low dosage investigational sIPV in people with Polio and Post-Polio Syndrome, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and… Read more about this study
- Who is it for?
- Ages 60 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Polio and Post-Polio Syndrome
- What is being tested?
- Three-dose regimen of high dosage investigational sIPV, Three-dose regimen of medium dosage investigational sIPV and Three-dose regimen of low dosage investigational sIPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2017to 28 Dec 2018
- Phase
- Phase 2
- 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 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy volunteer aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;
- Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
- Axillary temperature ≤ 37.0 °C;
Who cannot join
- Preterm or low birth weight infants;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- History of polio;
- Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- Autoimmune disease or immunodeficiency/immunosuppressive;
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- Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
- Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
- Mother of the participant has HIV infection;
- Acute illness or acute exacerbation of chronic disease within the past 7 days;
- Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
- Receipt of any subunit or inactivated vaccine within the past 7 day;
- Receipt of any live attenuated vaccine within the past 14 days;
- Receipt of any blood product within the past 3 months;
- Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.
This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.
- Conditions
- Polio and Post-Polio Syndrome
- Being tested
- Three-dose regimen of high dosage investigational sIPV, Three-dose regimen of medium dosage investigational sIPV, Three-dose regimen of low dosage investigational sIPV, Three-dose regimen of commercialized sIPV, Three-dose regimen of commercialized IPV
- Medical subject headings
- Postpoliomyelitis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dose regimen of high dosage investigational sIPVBiological
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
Three-dose regimen of medium dosage investigational sIPVBiological
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
Three-dose regimen of low dosage investigational sIPVBiological
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
Three-dose regimen of commercialized sIPVBiological
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
Three-dose regimen of commercialized IPVBiological
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - High dosage | Experimental | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV Receives: Biological: Three-dose regimen of high dosage investigational sIPV |
| Experimental Group - Medium dosage | Experimental | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV Receives: Biological: Three-dose regimen of medium dosage investigational sIPV |
| Experimental Group - Low dosage | Experimental | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV Receives: Biological: Three-dose regimen of low dosage investigational sIPV |
| Control Group -commercialized sIPV | Active comparator | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV Receives: Biological: Three-dose regimen of commercialized sIPV |
| Control Group -commercialized IPV | Active comparator | Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV Receives: Biological: Three-dose regimen of commercialized IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rates (SCRs) of each group after three-dose regimen
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Measured: 28~42 days
The post-immune geometric mean titer (GMT) of each group after three-dose regimen
GMT of each group 28~42 days after three-dose regimen.
Measured: 28~42 days
The geometric mean fold increase (GMI) of each group after three-dose regimen
The GMI is the increase of post-immune GMT from pre-immune GMT.
Measured: 28~42 days
Secondary outcomes (3)
The incidences of solicited adverse events (AEs) of each group
Solicited AEs occurred within 7 days after each injection will be collected.
Measured: 7 days
The incidences of unsolicited adverse events (AEs) of each group
Unsolicited AEs occurred within 30 days after each injection will be collected.
Measured: 30 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after each injection will be collected.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start28 Dec 2017
- Primary completion26 May 2018
- Study completion28 Dec 2018
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 Polio and Post-Polio SyndromeStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902054
- Sponsor's protocol ID
- JSVCT042
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1.
PubMed 32867698
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.
- ClinicalTrials.gov ID
- NCT03902054
- Acronym / sponsor ID
- JSVCT042
- Conditions
- Polio and Post-Polio Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 26 May 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 3 Apr 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.
This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - High dosage | Experimental | Biological: Three-dose regimen of high dosage investigational sIPVThree intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV |
| Experimental Group - Medium dosage | Experimental | Biological: Three-dose regimen of medium dosage investigational sIPVThree intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV |
| Experimental Group - Low dosage | Experimental | Biological: Three-dose regimen of low dosage investigational sIPVThree intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV |
| Control Group -commercialized sIPV | Active comparator | Biological: Three-dose regimen of commercialized sIPVThree intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV |
| Control Group -commercialized IPV | Active comparator | Biological: Three-dose regimen of commercialized IPVThree intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV |
Who may qualify
- Ages
- 60 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy volunteer aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;
- Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
- Axillary temperature ≤ 37.0 °C;
Key exclusion criteria (15 listed)
- Preterm or low birth weight infants;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- History of polio;
- Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
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 |
|---|---|---|
| Three-dose regimen of high dosage investigational sIPVThe investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. | Biological | Experimental Group - High dosage |
| Three-dose regimen of medium dosage investigational sIPVThe investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. | Biological | Experimental Group - Medium dosage |
| Three-dose regimen of low dosage investigational sIPVThe investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. | Biological | Experimental Group - Low dosage |
| Three-dose regimen of commercialized sIPVThe control vaccine was manufactured by Chinese Academy of Medical Sciences. | Biological | Control Group -commercialized sIPV |
| Three-dose regimen of commercialized IPVThe control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO). | Biological | Control Group -commercialized IPV |
Primary outcome
The seroconversion rates (SCRs) of each group after three-dose regimen
Time frame: 28~42 days
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The post-immune geometric mean titer (GMT) of each group after three-dose regimen
Time frame: 28~42 days
GMT of each group 28~42 days after three-dose regimen.
The geometric mean fold increase (GMI) of each group after three-dose regimen
Time frame: 28~42 days
The GMI is the increase of post-immune GMT from pre-immune GMT.
3 secondary outcomes
The incidences of solicited adverse events (AEs) of each group
Time frame: 7 days
The incidences of unsolicited adverse events (AEs) of each group
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group
Time frame: 30 days
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 3 Apr 2019.
- Derived from this study: PubMed 32867698Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Three-dose regimen of high dosage investigational sIPV, Three-dose regimen of medium dosage investigational sIPV and Three-dose regimen of low dosage investigational sIPV in people with Polio and Post-Polio Syndrome, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site 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 4 inclusion and 15 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 3 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The seroconversion rates (SCRs) of each group after three-dose regimen (time frame: 28~42 days). The study lists 3 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 NCT03902054, 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 3 Apr 2019.