Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-5
SponsorSinovac Biotech Co., Ltd
About this trial
The goal of this clinical trial is to evaluate the immunogenicity, safety, and immune persistence of the primary series of an investigational group ACYW135 meningococcal conjugate vaccine, as well as the immunogenicity and safety of a booster dose administered at 12 months of age, in healthy children aged 3 to 5 months.
The main questions it aims to answer are:
Is the immune response induced by the primary series of the investigational vaccine non-inferior to that of the licensed control vaccine? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide immune persistence up to 12 months of age? What is the immunogenicity of a booster dose administered at 12 months of age? Researchers will compare the investigational vaccine group with the active comparator group (CanSinoBIO MCV-ACYW) during both the primary immunization phase and the booster phase.
Participants will:
Be randomly assigned in a 1:1 ratio to receive either three doses of the investigational vaccine or three doses of the control vaccine according to a 0,1,2-month schedule during the primary immunization phase; Receive a booster dose at 12 months of age (either investigational vaccine or control vaccine according to group assignment); Provide blood samples at four time points: before primary vaccination, 30 days after primary vaccination, before booster vaccination (12 months of age), and 30 days after booster vaccination; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after the last dose administered; A total of 880 participants will be enrolled.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy participants aged 3 to 5 months.
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; 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 any meningococcal vaccine (including but not limited to: Group A meningococcal polysaccharide vaccine, Group A/C meningococcal polysaccharide/conjugate vaccine, ACYW135 meningococcal polysaccharide/conjugate vaccine, etc.).
Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother), current perianal abscess, or severe eczema.
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 Conjugate Vaccine (CRM197)
Treatment groups
880 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 three-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame
Day 30 after three-dose 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 three-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
Time frame
Day 30 after three-dose 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 three-dose vaccination in baseline seronegative participants
Time frame
Day 30 after three-dose 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 three-dose vaccination in baseline seronegative participants
Time frame
Day 30 after three-dose 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 three-dose vaccination in the overall study population
Time frame
Day 30 after three-dose 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 three-dose vaccination in the overall study population
Time frame
Day 30 after three-dose vaccinationSponsors and contacts
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Source ClinicalTrials.gov