Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-6
SponsorSinovac Biotech Co., Ltd
About this trial
The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 meningococcal conjugate vaccine in healthy children aged 2 to 6 years.
The main questions it aims to answer are:
Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine, as measured by serum antibody levels? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the control group (licensed ACYW135 polysaccharide vaccine) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile.
Participants will:
Receive a single dose of either the investigational vaccine or the control vaccine by intramuscular injection; Provide two blood samples (before vaccination and 30 days after) for antibody testing; Have their vaccination site and overall health monitored for AE/AR immediately after injection, for 7 days and for 30 days through diary card and follow-up contacts; Be followed for serious adverse events for 6 months after vaccination. A total of 660 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy participants aged 2 to 6 years.
The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.
Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.
Provision of legal identification documentation.
Disqualifiers
History (or suspected history) of meningococcal disease.
History of infantile wheezing/asthma; history of allergy to the vaccine or any vaccine components (Group A/C/Y/W135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.
Prior vaccination with Group A or Group A/C meningococcal polysaccharide vaccine with an interval ≤1 year since the most recent dose; prior vaccination with any meningococcal polysaccharide/polysaccharide conjugate vaccine other than Group A or Group A/C meningococcal polysaccharide vaccines (including but not limited to: ACYW135 meningococcal polysaccharide vaccine, Group A/C meningococcal polysaccharide conjugate vaccine, ACYW135 meningococcal polysaccharide conjugate vaccine).
Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection in the participant or the participant's mother).
Trial design
Design model
Parallel
Treatments tested in this trial
experimental vaccine
Biological/Vaccinegroup ACYW135 meningococcal conjugate vaccine
active comparator vaccine
Biological/Vaccinegroup ACYW135 meningococcal polysaccharide vaccine
Treatment groups
660 Participants
are divided into 2 treatment groupsGroup A: experimental groupExperimental treatment 1 intervention
Group B: active comparator groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135
seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame
Day 30 after vaccination2
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame
Day 30 after vaccinationSecondary outcomes
1
Seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
Seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants
Time frame
Day 30 after vaccination2
GMIs of Nm antibodies for serogroups A, C, Y, W135
GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in baseline seronegative participants
Time frame
Day 30 after vaccination3
Seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seroconversion rates and seropositive rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in the overall study population
Time frame
Day 30 after vaccination4
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after vaccination in the overall study population
Time frame
Day 30 after vaccinationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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