PoliomyelitisPhase 3NCT06752174
A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants
A Phase 3 study testing sIPV+bOPV and wIPV+bOPV in people with Poliomyelitis, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy 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?
- sIPV+bOPV and wIPV+bOPV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2023to 12 Apr 2024
- 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 permanent residents aged 2 months (over 60 days and less than 90 days);
- Infant's legal guardians agree to sign the informed consent forms voluntarily;
- Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
- Armpit temperature ≤ 37.0 ℃
Who cannot join
- Preterm birth (delivery before the 37th week of pregnancy).
- Previous vaccination against polio.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- History of polio.
- History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
- History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
Show all 15Show fewer
- Individuals with immunodeficiency or receiving immunosuppression therapy.
- Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.
- Known or suspected concomitant diseases include: respiratory disease, acute infection or active chronic disease, cardiovascular disease, liver and kidney disease, skin disease, mother with HIV infection.
- Administration of blood or blood-related products or immunoglobulins (hepatitis B immunoglobulins is acceptable).
- History of administration of live attenuated vaccines within 14 days.
- History of administration of subunit or inactivated vaccines within 7 days.
- Individuals with any acute diseases within 7 days, receiving antibiotics or antiviral therapy.
- Fever within 3 days (Armpit temperature ≥38.0 ℃).
- Use of any investigational product recently, or have any conditions that the investigator believes may affect the evaluation of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Center for Diseases Control and Prevention
Jinan, Shandong, 250014
About this study
Official title: A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants
The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.
Read the detailed description
A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.
- Conditions
- Poliomyelitis
- Being tested
- sIPV+bOPV, wIPV+bOPV
- Keywords
- sIPV, bOPV, sequential immune
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPV+bOPVBiological
2+1 sequential" immunization program (sIPV-sIPV-bOPV)
wIPV+bOPVBiological
2+1 sequential" immunization program (wIPV-wIPV-bOPV)
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants Receives: Biological: sIPV+bOPV |
| control group | Active comparator | control group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants Receives: Biological: wIPV+bOPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody
Measured: Day 30 post full vaccination
Secondary outcomes (6)
GMT of poliovirus type I, type II and type III neutralizing antibody
Measured: Day 30 post full vaccination
GMI of poliovirus type I, type II and type III neutralizing antibody
Measured: Day 30 post full vaccination
The seropositive rates of poliovirus type I, type II and type III neutralizing antibody
Measured: Day 30 post full vaccination
The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64
Measured: Day 30 post full vaccination
Incidence of adverse reactions/events
Measured: 30 days after each dose of vaccination
Incidence of serious adverse events (SAE)
Measured: From the first immunization to 6 months after the last immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start8 Mar 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752174
- Sponsor's protocol ID
- 2017L00935-2
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants
- ClinicalTrials.gov ID
- NCT06752174
- Acronym / sponsor ID
- 2017L00935-2
- Conditions
- Poliomyelitis
- Keywords
- sIPV, bOPV, sequential immune
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Beijing Minhai Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 30 Dec 2024 (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 goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.
Detailed description
A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Biological: sIPV+bOPVstudy group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants |
| control group | Active comparator | Biological: wIPV+bOPVcontrol group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants |
Who may qualify
- Ages
- 60 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy permanent residents aged 2 months (over 60 days and less than 90 days);
- Infant's legal guardians agree to sign the informed consent forms voluntarily;
- Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
- Armpit temperature ≤ 37.0 ℃
Key exclusion criteria (15 listed)
- Preterm birth (delivery before the 37th week of pregnancy).
- Previous vaccination against polio.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- History of polio.
- History or family history of convulsions, seizures, encephalopathy, and neurological 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 |
|---|---|---|
| sIPV+bOPV2+1 sequential" immunization program (sIPV-sIPV-bOPV) | Biological | study group |
| wIPV+bOPV2+1 sequential" immunization program (wIPV-wIPV-bOPV) | Biological | control group |
Primary outcome
The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
6 secondary outcomes
GMT of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
GMI of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
The seropositive rates of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64
Time frame: Day 30 post full vaccination
Incidence of adverse reactions/events
Time frame: 30 days after each dose of vaccination
Incidence of serious adverse events (SAE)
Time frame: From the first immunization to 6 months after the last immunization
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 30 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Poliomyelitis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
RecruitingPhase 3
A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
Poliomyelitis
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 3 study testing sIPV+bOPV and wIPV+bOPV in people with Poliomyelitis, run by Beijing Minhai Biotechnology 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 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 30 Dec 2024. 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 positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody (time frame: Day 30 post full vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2024.