Phase IV Study of Concomitant Administration of the sIPV and HepA
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-4
SponsorInstitute of Medical Biology, Chinese Academy of Medical Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
sIPV (booster dose at 18 months of age)
Biological/VaccineSabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose at 18 months of age for the booster one
HepA-L
Biological/VaccineFreeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age
HepA-I
Biological/VaccineInactivated hepatitis A virus vaccine, 0.5mL for each dose, two doses at 18 and 24 months of age, respectively
Treatment groups
2,000 Participants
are divided into 5 treatment groupsGroup A: sIPV + HepA-L (coconmitant vaccination cohort)Experimental treatment 2 interventions
Group B: sIPV + HepA-I (coconmitant vaccination cohort)Experimental treatment 2 interventions
Group C: sIPV (individual vaccination cohort)Experimental treatment 1 intervention
Group D: HepA-L (individual vaccination cohort)Experimental treatment 1 intervention
Group E: HepA-I (individual vaccination cohort)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 vaccination2
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 vaccination3
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 vaccination4
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 vaccinationSecondary outcomes
1
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 vaccination2
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 vaccination3
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 vaccination4
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 vaccinationSponsors and contacts
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Source ClinicalTrials.gov
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