A Phase 4 interventional study of sIPV (booster dose at 18 months of age) and HepA-L in Polio and Hepatitis A, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences. Not yet recruiting at 3 sites in China. Open to participants aged 4 Months to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences · Phase 4, Interventional, and Prevention
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.
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.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Institute of Medical Biology, Chinese Academy of Medical Sciences is the lead sponsor of 29 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concomitant administration of sIPV and HepA-L at 18 months of age
Biological: sIPV (booster dose at 18 months of age) · Biological: HepA-L
Concomitant administration of sIPV and HepA-I at 18 months of age, and another dose administration of HepA-I at 24 months of age
Biological: sIPV (booster dose at 18 months of age) · Biological: HepA-I
One booster dose of sIPV at 18 months of age
Biological: sIPV (booster dose at 18 months of age)
One dose of Hep-L at 18 months of age
Biological: HepA-L
Two doses of Hep-I at 18 and 24 months of age, respectively
Biological: HepA-I
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose at 18 months of age for the booster one
Freeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age
Inactivated hepatitis A virus vaccine, 0.5mL for each dose, two doses at 18 and 24 months of age, respectively
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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Between baseline and day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Between baseline and Day 30 after vaccination
Safety index-incidence of adverse events
Incidence of adverse events after vaccination
Time frame: 0-30 minutes after vaccination
Safety index-incidence of solicited adverse events
Incidence of solicited local and systematic adverse events after vaccination
Time frame: Day 0-7 or Day 0-14 after vaccination
Safety index-incidence of unsolicited adverse events
Incidence of unsolicited adverse events after vaccination
Time frame: Day 0-30 after vaccination
Safety index-incidence of adverse events
Incidence of adverse events after vaccination
Time frame: Day 0-30 after vaccination
Safety index-incidence of serious adverse events
Incidence of serious adverse events
Time frame: From the beginning of the vaccination up to 6 months after vaccination completed
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2024; primary completion for Aug 2026, 26 months later.
Of 30 phase 4 interventional studies under Poliomyelitis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's planned 26 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Institute of Medical Biology, Chinese Academy of Medical Sciences