Study of Concomitant Administration of the sIPV and DTaP or MMR
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-2
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 DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after basic immunization. Secondary immunogenicity endpoints include the seropositive rates, seroconversion rates, geometric mean titer/concentration (GMT/GMC), geometric mean fold increase (GMFI) of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies 30 days after full immunization. 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: Infants aged 2 months at the time of enrollment
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.
Disqualifiers
Vaccination History: received vaccines containing diphtheria-tetanus-pertussis antigens, polio antigens, Hib conjugate vaccine, or 13-valent pneumococcal conjugate vaccine before enrollment.
Those who had received blood transfusions or used blood products (except hepatitis B immunoglobulin) before enrollment.
Recent Vaccination: 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 before enrollment, or have used antipyretic analgesics or antihistamines within 3 days.
Trial design
Design model
Parallel
Treatments tested in this trial
sIPV
Biological/VaccineSabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaP
Biological/VaccineAdsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
bOPV 1,3
Biological/VaccinePoliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose
MMR Vaccine
Biological/VaccineMeasles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose
Treatment groups
2,640 Participants
are divided into 4 treatment groupsGroup A: sIPV + DTaP (concomitant vaccination cohort)Experimental treatment 2 interventions
Group B: sIPV/bOPV + DTaP (concomitant vaccination cohort)Experimental treatment 3 interventions
Group C: sIPV + DTaP + MMR (systematic interval-based vaccination cohort)Experimental treatment 3 interventions
Group D: sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort)Experimental treatment 3 interventions
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 basic 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 basic 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 basic vaccination4
Immunogenicity index-seroconversion rate of anti-DT antibody
Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (Antibody Concentration\<0.1 IU/ml) to seropositive (Antibody Concentration≥0.1 IU/ml), or a ≥4-fold increase from baseline.
Time frame
Between baseline and day 30 after basic vaccinationSecondary outcomes
1
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8
Time frame
Day 30 after basic vaccination2
Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8
Time frame
Day 30 after full vaccination3
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8
Time frame
Day 30 after basic vaccination4
Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method. Seropositive will be defined as the antibody tie ≥1:8
Time frame
Day 30 after full vaccinationSponsors and contacts
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Source ClinicalTrials.gov
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