Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine

January 20, 2026 updated by: Sinovac Life Sciences Co., Ltd.

An Open-Label Combined Randomized, Blinded, Placebo- and Active-Controlled Phase Ia Clinical Trial: Evaluate the Safety and Immunogenicity of the Group ACYW135X Meningococcal Conjugate Vaccine in Individuals Aged 2 to 59 Years

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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;
  • Participants of childbearing potential and their sexual partners shall voluntarily adopt effective contraceptive measures from the date of signing the informed consent form until 3 months after the administration of the investigational vaccine, with no plans for sperm or egg donation during this period.

Exclusion Criteria:

  • 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);
  • Presence of coagulation disorders (e.g., coagulation factor deficiency, thrombocytopathy), or a history of significant bleeding, hematoma, or ecchymosis following previous intramuscular injection or venipuncture;
  • History of severe diseases or current diagnosis of severe chronic diseases (including but not limited to severe cardiovascular diseases, uncontrolled hypertension, hematological diseases, hepatic and renal diseases, gastrointestinal diseases, respiratory diseases, malignant tumors, and history of major organ transplantation);
  • Presence of severe congenital malformations, genetic defects, or malnutrition;
  • Presence or history of severe neurological diseases (epilepsy, convulsions, or seizures) or psychiatric disorders, or a family history of psychiatric disorders;
  • Chronic alcohol abuse [weekly alcohol consumption > 14 standard drinks (1 standard drink = 14 grams of 100% alcohol ≈ 360 mL beer, 150 mL wine, or 45 mL distilled spirits/liquor)] or a history of substance abuse (repeated and excessive use of narcotic drugs, psychotropic drugs, volatile organic solvents, etc.);
  • Receipt of immunosuppressive therapy or other immunomodulatory therapy for ≥ 14 days within the past 6 months (prednisone ≥ 20 mg/day or ≥ 2 mg/kg/day, or its equivalent dose); receipt of cytotoxic therapy; or planned receipt of such therapies during the study period;
  • Receipt of blood products within 3 months prior to the administration of the investigational vaccine;
  • Receipt of other investigational drugs or vaccines within 3 months prior to the administration of the investigational vaccine, or planned receipt of such drugs or vaccines during the study period;
  • Receipt of live attenuated vaccines or nucleic acid vaccines within the past 14 days, or receipt of subunit vaccines or inactivated vaccines within the past 7 days;
  • Participants who are breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this trial;
  • Presence of any acute diseases or acute exacerbation of chronic diseases within the past 7 days, or known or suspected active infections;

  • Clinically significant abnormal findings in laboratory tests：

    1. Hematological parameters: white blood cell count, hemoglobin, platelet count;
    2. Biochemical parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), blood glucose;
    3. Urinalysis parameters: urine protein (PRO);
  • Axillary temperature > 37.0℃ prior to vaccination, or other vital sign measurements beyond the reference range;
  • Presence of skin damage, inflammation, ulceration, rash, or scarring at the intended injection site that may interfere with vaccination or observation of local reactions;
  • Any other factors that, in the investigator's judgment, render the participant unsuitable for participation in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high-dose experimental group
2~59 years old
Biological: high-dose Group ACYW135X Meningococcal Conjugate Vaccine
high-dose Group ACYW135X Meningococcal Conjugate Vaccine
Experimental: medium-dose experimental group
2~59 years old
Biological: medium-dose Group ACYW135X Meningococcal Conjugate Vaccine
medium-dose Group ACYW135X Meningococcal Conjugate Vaccine
Experimental: low-dose experimental group
2~6 years old
Biological: low-dose Group ACYW135X Meningococcal Conjugate Vaccine
low-dose Group ACYW135X Meningococcal Conjugate Vaccine
Placebo Comparator: placebo group
2~6 years old
Biological: Placebo
placebo
Active Comparator: active control group
2~3 years old
Biological: Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
Other Names:
  • Menhycia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety of experimental vaccine among participants in different age groups (based on adverse reactions)
Time Frame: 30 days
The incidence rates of adverse reactions 30 days after vaccination
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
Time Frame: 30 days
The incidence rate of adverse events 30 days after vaccination
30 days
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
Time Frame: 3 days
The incidence rate of clinically significant abnormal blood biochemistry, blood routine, and urine routine indexes within 3 days after vaccination
3 days
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
Time Frame: 6 months
The incidence rate of serious adverse events 6 months after vaccination
6 months
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
Time Frame: 30 days
The seropositive rates, seroconversion rate, GMT and GMFR of Nm antibody against serogroups A, C, Y, W135, and X at 30 days after vaccination
30 days
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
Time Frame: 30 days
The proportion of Nm antibody against serogroups A, C, Y, W135, and X with titer ≥ 1:16, ≥ 1:32, ≥ 1:64, and ≥ 1:128 at 30 days after vaccination
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac Life Sciences Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 21, 2026

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-ACYWX-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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