PoliomyelitisPhase 3NCT03526978
An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
A Phase 3 study testing Investigational sIPV in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants. Read more about this study
- Who is it for?
- Ages 60 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Investigational sIPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2017to 18 Apr 2018
- Phase
- Phase 3
- 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 between 60-90 days old;
- Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- Proven legal identity;
- Participants or 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;
Who cannot join
- Prior vaccination with Poliovirus Vaccine;
- 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;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
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- Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry;
- Blood product prior to study entry;
- Any other investigational medicine(s) within 30 days prior to study entry;
- Any live attenuated vaccine within 14 days prior to study entry;
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- Axillary temperature > 37.0 °C;
- Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Trial locations and contacts
1 site in 1 country.
China1 site
Pizhou County Center for Disease Control and Prevention
Pizhou, Jiangsu, 221300
About this study
Official title: A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
Read the detailed description
The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.
- Conditions
- Poliomyelitis
- Being tested
- Investigational sIPV, Control IPV
- Keywords
- Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational sIPVBiological
Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV
Control IPVBiological
Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
Intervention: investigational sIPV Receives: Biological: Investigational sIPV |
| Control Group | Active comparator | The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV Receives: Biological: Control 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 primary immunization.
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. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
Measured: 90 days
Secondary outcomes (15)
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 incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.
SAEs during the period of safety monitoring will be collected.
Measured: 90-420 days.
The post-immune antibody positive rate of each group after primary immunization.
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
Measured: 90 days
The post-immune geometric mean titer (GMT) of each group after primary immunization.
GMT of each group after primary immunization which lasts 60 days.
Measured: 90 days.
The geometric mean fold increase (GMI) of each group after primary immunization.
The GMI is the increase of post-immune GMT from pre-immune GMT.
Measured: 90 days
The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.
Percentage of subjects with antibody ≥ 1:64 of each group after three-dose
Measured: 90 days
The antibody positive rate of each group before booster dose.
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months.
Measured: 420 days
The geometric mean titer (GMT) of each group before booster dose.
GMT of each group before booster dose which occurred at the age of 18months.
Measured: 420 days.
The geometric mean fold increase (GMI) of each group before booster dose.
The GMI is the increase of post-immune GMT from pre-i mmune GMT.
Measured: 420 days
The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.
Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months.
Measured: 420 days
The post-immune antibody positive rate of each group after booster dose.
Subjects whose post-immune antibody level ≥ 1:8 are co
nsidered antibody positive
Measured: 570 days
The post-immune geometric mean titer (GMT) of each group after booster dose.
GMT of each group after booster dose. The booster dose at the age of 18months
Measured: 570 days
The geometric mean fold increase (GMI) of each group after booster dose.
The GMI is the increase of post-immune GMT from pre-immune GMT.
Measured: 570 days
The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.
Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months.
Measured: 570 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start8 Aug 2017
- Primary completion18 Oct 2017
- Study completion18 Apr 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 PoliomyelitisStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuemei Hu, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526978
- Sponsor's protocol ID
- PRO-sIPV-3001
- Status last verified
- Jan 2019
- First submitted
- 4 May 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu Y, Wang J, Zeng G, Chu K, Jiang D, Zhu F, Ying Z, Chen L, Li C, Zhu F, Yin W. Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial. J Infect Dis. 2019 Oct 8;220(10):1551-1557. doi: 10.1093/infdis/jiy736.
PubMed 30958543
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
- ClinicalTrials.gov ID
- NCT03526978
- Acronym / sponsor ID
- PRO-sIPV-3001
- Conditions
- Poliomyelitis
- Keywords
- Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 16 May 2018 (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 phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
Detailed description
The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Investigational sIPVThe investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd. Intervention: investigational sIPV |
| Control Group | Active comparator | Biological: Control IPVThe control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV |
Who may qualify
- Ages
- 60 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy volunteer between 60-90 days old;
- Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- Proven legal identity;
- Participants or 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;
Key exclusion criteria (14 listed)
- Prior vaccination with Poliovirus Vaccine;
- 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;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
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 |
|---|---|---|
| Investigational sIPVThree intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV | Biological | Experimental Group |
| Control IPVThree intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV | Biological | Control Group |
Primary outcome
The seroconversion rates (SCRs) of each group after primary immunization.
Time frame: 90 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. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
15 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 incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.
Time frame: 90-420 days.
The post-immune antibody positive rate of each group after primary immunization.
Time frame: 90 days
The post-immune geometric mean titer (GMT) of each group after primary immunization.
Time frame: 90 days.
The geometric mean fold increase (GMI) of each group after primary immunization.
Time frame: 90 days
The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.
Time frame: 90 days
The antibody positive rate of each group before booster dose.
Time frame: 420 days
The geometric mean titer (GMT) of each group before booster dose.
Time frame: 420 days.
The geometric mean fold increase (GMI) of each group before booster dose.
Time frame: 420 days
The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.
Time frame: 420 days
The post-immune antibody positive rate of each group after booster dose.
Time frame: 570 days
The post-immune geometric mean titer (GMT) of each group after booster dose.
Time frame: 570 days
The geometric mean fold increase (GMI) of each group after booster dose.
Time frame: 570 days
The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.
Time frame: 570 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 25 Jan 2019.
- Derived from this study: PubMed 30958543Hu Y, Wang J, Zeng G, Chu K, Jiang D, Zhu F, Ying Z, Chen L, Li C, Zhu F, Yin W. Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial. J Infect Dis. 2019 Oct 8;220(10):1551-1557. doi: 10.1093/infdis/jiy736.
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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.
Yuemei Hu principal investigator
Jiangsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational sIPV in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd 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 5 inclusion and 14 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 25 Jan 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 primary immunization. (time frame: 90 days). 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 NCT03526978, 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 25 Jan 2019.