PolioPhase 4NCT06460545
Phase IV Study of Concomitant Administration of the sIPV and HepA
A Phase 4 study testing sIPV (booster dose at 18 months of age), HepA-L and HepA-I in people with Polio and Hepatitis A, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 3 sites in China.
Trial summary
This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. Read more about this study
- Who is it for?
- Ages 4 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Polio, Hepatitis A
- What is being tested?
- sIPV (booster dose at 18 months of age), HepA-L and HepA-I
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jun 2024to 15 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 4 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age Requirement: Children aged 4 months at the time of enrollment
- Vaccination Requirement: volunteers have already taken administration 2 doses of sabin-strain-based inactivated poliovirus vaccine (produced by IMBCAMS), and have not yet been injected with the third dose containing poliovirus antigen.
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, and sign the informed consent form.
- Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.
- Birth condition: Full-term birth (37~42 gestational weeks) and normal birth weight (no less than 2500g).
- Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.
Who cannot join
- Health Requirement: Volunteers cannot meet health requirements through physical examinations.
- History of Related Illness: Volunteers have a history of developing Hepatitis A, poliomyelitis, or immunodeficiency.
- Birth Condition: Volunteers have a history of abnormal labor stage, asphyxia, nervous system damage, or clinically confirmed pathologic jaundice。
- Allergic History: Volunteers have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions.
- Vaccine History: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.
- Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine.
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- Neurological and Mental Health: Volunteers have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions.
- Health Conditions: Volunteers have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.
- Coagulation Abnormalities: Volunteers have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders).
- Infectious Diseases: Volunteers have infectious diseases that may affect the study, such as human immunodeficiency virus (HIV) infection, hepatitis, and tuberculosis.
- Special Condition: Volunteers who could not tolerate venipuncture, or had a history of needle and blood sickness.
- Organ Removal History: Volunteers have a history of organ removal (e.g., thyroid, pancreas, liver, spleen).
- History of Blood Products: Volunteers have a history of loss of blood, blood transfusion, the use of adjuvant therapies, or immunoglobulin within 3 months prior to vaccination.
- Immune Therapy: Volunteers have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination.
- Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.
- Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Jiu Longpo District Center for Disease Control and Disease
Chongqing, Chongqing Municipality
Yuan Yao, 023-68198622, 71165057@qq.com
Wanzhou District Center for DIsease Control and Prevention
Chongqing, Chongqing Municipality
Liang Tang, 023-58131537 ext. +86, 284245548@qq.com
Jiangjin District Center for Disease Control and Prevention
Chongqing, Chonqing
Kai Zhang, 023-47562909, 398478821@qq.com
About this study
Official title: Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Freeze-dried Live-attenuated Hepatitis A Vaccine or Inactivated Hepatitis A Vaccine
This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT/GMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.
Read the detailed description
This is a randomized, open-labeled, parallel phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I. 2000 children subjects aged 4 months will be enrolled to take administration of 1 dose of sIPV. All participants at 18 months of age will be randomly assigned to 5 cohorts in a ratio of 4:4:4:3:3, that is, (1) 400 subjects will be concomitantly injected with sIPV and HepA-L, (2) 400 subjects will be concomitantly injected with sIPV and HepA-I, and another dose of HepA-I at 24 months of age (3) 400 subjects will be only injected one dose of sIPV, (4) 300 subjects will be only injected with one dose of HepA-L, (5) 300 subjects will be only injected with two doses of HepA-I at 18 and 24 months of age, respectively.
For safety assessment, adverse events after the third dose of sIPV at 4 months of age would be collected through phone-call follow-ups on Day 8 and Day 30 after the injection by investigators and active reports from participants' guardians. At 18 months of age, safety data would be recorded through the diary and contact cards by participants' guardians to collect solicited or unsolicited AEs in periods of solicitation and nonsolicitation, respectively. From 31 days after the final dose to 6 months later, serious adverse events will be evaluated by the investigator via phone call or active reports by participants' guardians.
For immunogenicity assessment, blood samples before each dose on Day 0 and Day 30 after each injection would be collected to evaluate the type I, II, and III anti-poliovirus neutralizing antibody levels or/and anti-hepatitis A virus antibody for different groups.
- Conditions
- Polio, Hepatitis A
- Being tested
- sIPV (booster dose at 18 months of age), HepA-L, HepA-I
- Medical subject headings
- Poliomyelitis, Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPV (booster dose at 18 months of age)Biological
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose at 18 months of age for the booster one
HepA-LBiological
Freeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age
HepA-IBiological
Inactivated hepatitis A virus vaccine, 0.5mL for each dose, two doses at 18 and 24 months of age, respectively
| Study group | Role | What they receive |
|---|---|---|
| sIPV + HepA-L (coconmitant vaccination cohort) | Experimental | Concomitant administration of sIPV and HepA-L at 18 months of age Receives: Biological: sIPV (booster dose at 18 months of age); Biological: HepA-L |
| sIPV + HepA-I (coconmitant vaccination cohort) | Experimental | Concomitant administration of sIPV and HepA-I at 18 months of age, and another dose administration of HepA-I at 24 months of age Receives: Biological: sIPV (booster dose at 18 months of age); Biological: HepA-I |
| sIPV (individual vaccination cohort) | Experimental | One booster dose of sIPV at 18 months of age Receives: Biological: sIPV (booster dose at 18 months of age) |
| HepA-L (individual vaccination cohort) | Experimental | One dose of Hep-L at 18 months of age Receives: Biological: HepA-L |
| HepA-I (individual vaccination cohort) | Experimental | Two doses of Hep-I at 18 and 24 months of age, respectively Receives: Biological: HepA-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
Measured: Between baseline and day 30 after vaccination
Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
Measured: Between baseline and day 30 after vaccination
Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
Measured: Between baseline and day 30 after vaccination
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).
Measured: Day 30 after vaccination
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).
Measured: Day 30 after vaccination
Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).
Measured: Day 30 after vaccination
Immunogenicity index-seroconversion rate of anti-hepatitis A virus antibody
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (<20mIU/ml) to seropositive (≥20mIU/ml), or a ≥4-fold increase from baseline
Measured: Between baseline and day 30 after vaccination
Secondary outcomes (14)
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-hepatitis A virus antibody
Antibody assay will be performed using the ELISA method.
Measured: Day 30 after vaccination
Immunogenicity index-seropositive rate of anti-hepatitis A virus antibody
Antibody assay will be performed using the ELISA method. Seropositive will be defined as the level (≥20mIU/ml).
Measured: Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Measured: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of anti-hepatitis A virus antibody
Antibody assay will be performed using the ELISA method.
Measured: Between baseline and Day 30 after vaccination
Safety index-incidence of adverse events
Incidence of adverse events after vaccination
Measured: 0-30 minutes after vaccination
Safety index-incidence of solicited adverse events
Incidence of solicited local and systematic adverse events after vaccination
Measured: Day 0-7 or Day 0-14 after vaccination
Safety index-incidence of unsolicited adverse events
Incidence of unsolicited adverse events after vaccination
Measured: Day 0-30 after vaccination
Safety index-incidence of adverse events
Incidence of adverse events after vaccination
Measured: Day 0-30 after vaccination
Safety index-incidence of serious adverse events
Incidence of serious adverse events
Measured: From the beginning of the vaccination up to 6 months after vaccination completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiawei Xu, Principal investigator, Chongqing Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460545
- Sponsor's protocol ID
- sIPV-402
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Freeze-dried Live-attenuated Hepatitis A Vaccine or Inactivated Hepatitis A Vaccine
- ClinicalTrials.gov ID
- NCT06460545
- Acronym / sponsor ID
- sIPV-402
- Conditions
- Polio, Hepatitis A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 14 Jun 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.
This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT/GMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.
Detailed description
This is a randomized, open-labeled, parallel phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I. 2000 children subjects aged 4 months will be enrolled to take administration of 1 dose of sIPV. All participants at 18 months of age will be randomly assigned to 5 cohorts in a ratio of 4:4:4:3:3, that is, (1) 400 subjects will be concomitantly injected with sIPV and HepA-L, (2) 400 subjects will be concomitantly injected with sIPV and HepA-I, and another dose of HepA-I at 24 months of age (3) 400 subjects will be only injected one dose of sIPV, (4) 300 subjects will be only injected with one dose of HepA-L, (5) 300 subjects will be only injected with two doses of HepA-I at 18 and 24 months of age, respectively.
For safety assessment, adverse events after the third dose of sIPV at 4 months of age would be collected through phone-call follow-ups on Day 8 and Day 30 after the injection by investigators and active reports from participants' guardians. At 18 months of age, safety data would be recorded through the diary and contact cards by participants' guardians to collect solicited or unsolicited AEs in periods of solicitation and nonsolicitation, respectively. From 31 days after the final dose to 6 months later, serious adverse events will be evaluated by the investigator via phone call or active reports by participants' guardians.
For immunogenicity assessment, blood samples before each dose on Day 0 and Day 30 after each injection would be collected to evaluate the type I, II, and III anti-poliovirus neutralizing antibody levels or/and anti-hepatitis A virus antibody for different groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| sIPV + HepA-L (coconmitant vaccination cohort) | Experimental | Biological: sIPV (booster dose at 18 months of age), Biological: HepA-LConcomitant administration of sIPV and HepA-L at 18 months of age |
| sIPV + HepA-I (coconmitant vaccination cohort) | Experimental | Biological: sIPV (booster dose at 18 months of age), Biological: HepA-IConcomitant administration of sIPV and HepA-I at 18 months of age, and another dose administration of HepA-I at 24 months of age |
| sIPV (individual vaccination cohort) | Experimental | Biological: sIPV (booster dose at 18 months of age)One booster dose of sIPV at 18 months of age |
| HepA-L (individual vaccination cohort) | Experimental | Biological: HepA-LOne dose of Hep-L at 18 months of age |
| HepA-I (individual vaccination cohort) | Experimental | Biological: HepA-ITwo doses of Hep-I at 18 and 24 months of age, respectively |
Who may qualify
- Ages
- 4 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age Requirement: Children aged 4 months at the time of enrollment
- Vaccination Requirement: volunteers have already taken administration 2 doses of sabin-strain-based inactivated poliovirus vaccine (produced by IMBCAMS), and have not yet been injected with the third dose containing poliovirus antigen.
- Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, and sign the informed consent form.
- Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.
Key exclusion criteria (16 listed)
- Health Requirement: Volunteers cannot meet health requirements through physical examinations.
- History of Related Illness: Volunteers have a history of developing Hepatitis A, poliomyelitis, or immunodeficiency.
- Birth Condition: Volunteers have a history of abnormal labor stage, asphyxia, nervous system damage, or clinically confirmed pathologic jaundice。
- Allergic History: Volunteers have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions.
- Vaccine History: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.
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 (booster dose at 18 months of age)Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose at 18 months of age for the booster one | Biological | sIPV (individual vaccination cohort), sIPV + HepA-I (coconmitant vaccination cohort), sIPV + HepA-L (coconmitant vaccination cohort) |
| HepA-LFreeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age | Biological | HepA-L (individual vaccination cohort), sIPV + HepA-L (coconmitant vaccination cohort) |
| HepA-IInactivated hepatitis A virus vaccine, 0.5mL for each dose, two doses at 18 and 24 months of age, respectively | Biological | HepA-I (individual vaccination cohort), sIPV + HepA-I (coconmitant vaccination cohort) |
Primary outcome
Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after vaccination
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after vaccination
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody
Time frame: Between baseline and day 30 after vaccination
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody
Time frame: Day 30 after vaccination
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody
Time frame: Day 30 after vaccination
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).
Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody
Time frame: Day 30 after vaccination
Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).
Immunogenicity index-seroconversion rate of anti-hepatitis A virus antibody
Time frame: Between baseline and day 30 after vaccination
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (<20mIU/ml) to seropositive (≥20mIU/ml), or a ≥4-fold increase from baseline
14 secondary outcomes
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean concentration (GMC) of anti-hepatitis A virus antibody
Time frame: Day 30 after vaccination
Immunogenicity index-seropositive rate of anti-hepatitis A virus antibody
Time frame: Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of anti-hepatitis A virus antibody
Time frame: Between baseline and Day 30 after vaccination
Safety index-incidence of adverse events
Time frame: 0-30 minutes after vaccination
Safety index-incidence of solicited adverse events
Time frame: Day 0-7 or Day 0-14 after vaccination
Safety index-incidence of unsolicited adverse events
Time frame: Day 0-30 after vaccination
Safety index-incidence of adverse events
Time frame: Day 0-30 after vaccination
Safety index-incidence of serious adverse events
Time frame: From the beginning of the vaccination up to 6 months after vaccination completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
Jiawei Xu principal investigator
Chongqing Center for Disease Control and Prevention
3 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 sIPV (booster dose at 18 months of age), HepA-L and HepA-I in people with Polio and Hepatitis A, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 3 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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingsi Yang (0871-68334551 ext. +86, yjs@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody (time frame: Between baseline and day 30 after vaccination). The study lists 7 primary outcomes in all. 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 14 Jun 2024.