A Phase 3 interventional study of experimental vaccine and Active Comparator vaccine in Epidemic Meningitis and Meningococcal Vaccines, sponsored by Sinovac Biotech Co., Ltd. Recruiting at 2 sites in China. Open to participants aged 3 Months to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention
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.
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's planned enrollment of 880 is above the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: experimental vaccine
Biological: Active Comparator vaccine
Group ACYW135 Meningococcal Conjugate Vaccine
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
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 vaccination
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 vaccination
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 vaccination
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 vaccination
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 vaccination
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 vaccination
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 the overall study population
Time frame: Day 30 after three-dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 at Day 30 after three-dose vaccination in baseline seronegative participants and the overall study population
Time frame: Day 30 after three-dose vaccination
seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135
seropositive rates of Nm antibodies for serogroups A, C, Y, and W135 before the booster dose vaccination
Time frame: before the booster dose vaccination
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
GMTs of Nm antibodies for serogroups A, C, Y, and W135 before the booster dose vaccination
Time frame: before the booster dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 before the booster dose vaccination
Time frame: before the booster dose vaccination
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 the booster dose vaccination
Time frame: Day 30 after the booster dose vaccination
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 the booster dose vaccination
Time frame: Day 30 after the booster dose vaccination
GMIs of Nm antibodies for serogroups A, C, Y, W135
GMIs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after the booster dose vaccination
Time frame: Day 30 after the booster dose vaccination
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135
proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135 at Day 30 after the booster dose vaccination
Time frame: Day 30 after the booster dose vaccination
incidence of adverse reactions/events
incidence of adverse reactions/events within 30 minutes after each dose vaccination
Time frame: within 30 minutes after each dose vaccination
incidence of adverse reactions/events
incidence of adverse reactions/events within 0\~30 days after each dose vaccination
Time frame: within 0~30 days after each dose vaccination
incidence of serious adverse events
incidence of serious adverse events from the first dose to six months after the last dose vaccination
Time frame: from the first dose to six months after the last dose vaccination
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Apr 2027, 13 months after the start.
Of 25 phase 3 interventional studies under Meningitis, Meningococcal, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 20. This study's planned 13 months is above that.
How these figures are worked out, and which studies are left out of them.
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