Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-59
SponsorSinovac Life Sciences Co., Ltd.

About this trial

This trial adopts an open-label design combined with randomized, blinded, placebo-controlled and active-controlled design. The purpose of this trial is to evaluate the safety and immunogenicity of a Group ACYW135X Meningococcal Conjugate Vaccine. This study is planned to enroll 150 participants in total, with healthy individuals aged 2 to 59 years as participants. Among them, participants aged 18 to 59 years and 7 to 17 years will be assigned to the open-label design arm, while participants aged 4 to 6 years will be assigned to the randomized, blinded, placebo-controlled design arms.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy participants aged 2 to 59 years;

The participant and/or their legal guardian can understand and voluntarily sign the informed consent form (for participants aged 8 to 17 years, the form must be signed jointly by the participant and their legal guardian);

Be willing and able to comply with all visit schedules, sample collection procedures, vaccination protocols and other trial-related requirements, and maintain contact at any time during the study period;

Provide valid legal identification documents of the participant and/or their legal guardian;

Disqualifiers

History of meningococcal disease;

History of asthma; history of hypersensitivity to any vaccine or vaccine components (including serogroup A/C/Y/W135/X meningococcal capsular polysaccharide, mannitol, sucrose, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and water for injection), manifested as symptoms such as urticaria, dyspnea, or angioedema; or history of other severe adverse reactions following previous vaccination;

For children aged 2 to 6 years: history of previous vaccination with group ACYW135 meningococcal polysaccharide vaccine; or history of previous vaccination with any meningococcal conjugate vaccine other than group AC meningococcal conjugate vaccine; an interval of ≤ 12 months from the last dose of group A or group AC meningococcal polysaccharide vaccine or group AC meningococcal conjugate vaccine; history of vaccination with meningococcal conjugate vaccine since reaching 1 year of age. No vaccination history restrictions apply to participants aged 7 to 59 years;

Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);

Trial design

Design model

Sequential

Treatments tested in this trial

  • high-dose Group ACYW135X Meningococcal Conjugate Vaccine

    Biological/Vaccine

    high-dose Group ACYW135X Meningococcal Conjugate Vaccine

  • medium-dose Group ACYW135X Meningococcal Conjugate Vaccine

    Biological/Vaccine

    medium-dose Group ACYW135X Meningococcal Conjugate Vaccine

  • low-dose Group ACYW135X Meningococcal Conjugate Vaccine

    Biological/Vaccine

    low-dose Group ACYW135X Meningococcal Conjugate Vaccine

  • Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)

    Biological/Vaccine

    Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)

  • Placebo

    Biological/Vaccine

    placebo

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: high-dose experimental groupExperimental treatment 1 intervention
Group B: medium-dose experimental groupExperimental treatment 1 intervention
Group C: low-dose experimental groupExperimental treatment 1 intervention
Group D: placebo groupPlacebo comparator 1 intervention
Group E: active control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the safety of experimental vaccine among participants in different age groups (based on adverse reactions)

The incidence rates of adverse reactions 30 days after vaccination

Time frame
30 days

Secondary outcomes

1

Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)

The incidence rate of adverse events 30 days after vaccination

Time frame
30 days
2

Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)

The incidence rate of clinically significant abnormal blood biochemistry, blood routine, and urine routine indexes within 3 days after vaccination

Time frame
3 days
3

Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)

The incidence rate of serious adverse events 6 months after vaccination

Time frame
6 months
4

Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old

The seropositive rates, seroconversion rate, GMT and GMFR of Nm antibody against serogroups A, C, Y, W135, and X at 30 days after vaccination

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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