Phase IV Study of Concomitant Administration of the sIPV and HepA (NCT06460545) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Phase IV Study of Concomitant Administration of the sIPV and HepA
China2,000 participantsStarted 2024-06-15
Plain-language 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. 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.
Who can participate
Age range
4 Months – 4 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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: Vol…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody
Timeframe: Between baseline and day 30 after vaccination
2
Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody
Timeframe: Between baseline and day 30 after vaccination
3
Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody
Timeframe: Between baseline and day 30 after vaccination
4
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody
Timeframe: Day 30 after vaccination
5
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody
Timeframe: Day 30 after vaccination
6
Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody
Timeframe: Day 30 after vaccination
7
Trial details
NCT IDNCT06460545
SponsorInstitute of Medical Biology, Chinese Academy of Medical Sciences