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Meningococcal MeningitisPhase 3NCT06131554

A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

A Phase 3 study testing batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4), batch 2 of MCV4 and batch 3 of MCV4 in people with Meningococcal Meningitis, run by CanSino Biologics Inc. at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Meningitis
What is being tested?
batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4), batch 2 of MCV4 and batch 3 of MCV4
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,480 participants
Where
1 siteIndonesia
Study dates
20 Mar 2024to 4 Jun 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants aged 18-55 years old at the time of screening, who are in good health condition as determined by the study clinician.
  • Participants who have not been vaccinated with any meningococcal vaccines (including but not limited to meningococcal group A and C conjugate vaccine, meningococcal group A and C polysaccharide vaccine, Group ACYW135 Meningococcal polysaccharide/conjugate vaccine).
  • The participant or participant's legal guardian signs the informed consent form (ICF) and participant agrees to comply with the requirements of protocol and finish the 1-year follow-up.
  • Participants who are willing to discuss medical history with investigators or doctors and allow access to all medical records relevant to this trial.
  • Participants with child-bearing potential who are willing to practice adequate contraception methods from signing the ICF to 12 months after vaccination. This includes:
  • Abstinence from penile-vaginal intercourse,
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  • Hormonal contraceptives such as oral contraceptives (the pill), injectables, implants, patches or estrogen vaginal ring (a ring-shaped hormonal contraceptive device that is used inside the vagina),
  • Intrauterine device (IUD/Spiral),
  • Male partner sterilization (vasectomy) prior to the female subject's entry into the study, and this male is the sole partner for that subject,
  • Male condom combined with a vaginal spermicide (a substance that can kill the sperm cells inside the vagina) or female diaphragm, whether with or without a vaginal spermicide .
  • Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.

Who cannot join

  • Axillary temperature >37.5°C (99°F).
  • Have congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • A history of epilepsy, convulsions or history/family history of mental illness.
  • Have meningitis or a history of meningitis illness.
  • Positive result of urine pregnancy test (also required for women within one year of menopause), lactating women, or participant /his partner is planning to become pregnant within 1 year.
  • Hypersensitivity to a component or excipient of the vaccine used in this clinical trial (mainly: group A, C, Y or W135 meningococcal capsular polysaccharide, diphtheria toxoid or diphtheria antigen, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
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  • In the past 6 months (internal time < 6 months), participants have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid treatment, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, spray treatment of allergic rhinitis).
  • Received or plan to receive blood/plasma products or immunoglobulins throughout the study period or 60 days prior to study vaccination.
  • Use of non-prescription drugs such as antipyretic (e.g., acetaminophen) and anti-inflammatory drugs (e.g., ibuprofen, naproxen etc.) within 12 hours before the administration of vaccine.
  • Have severe hypertension that is not controlled by medication (at the time of field measurement: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).
  • Suffering from a severe chronic disease or a condition that is in a progressive stage and cannot be well controlled, such as thyroid disease
  • Participants with known or suspected diseases that are judged by the investigator to affect the vaccination assessment, for example, acute infectious diseases, severe respiratory disease, severe cardiovascular disease, severe allergic skin disease etc.
  • History of serious adverse reactions associated with the vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.
  • Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., HIV infection, history of pancreatic, liver, spleen, kidney disease or history of resection).
  • Positive for HIV, Hepatitis B, Hepatitis C or Syphilis.
  • Bleeding constitution or condition associated with prolonged bleeding for which intramuscular injection is contraindicated in the opinion of the investigator.
  • Administration of live attenuated vaccine within 14 days or other vaccines within 7 days.
  • Participation in other studies involving interventional studies within 28 days prior to screening and/or during study participation.
  • According to the judgment of the investigator, participants could be excluded due to various medical, psychological, social or other conditions that are contrary to the trial protocol or that affect the subject's ability to sign informed consent.
  • Investigator site staff directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members，sponsor staff and their respective family members.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Husada Utama Hospital

    Surabaya, 60131

Other trials in Indonesia

About this study

Official title: A Multicenter, Randomized, Double-blinded, Positive-controlled Phase Ⅲ Clinical Trial to Evaluate Lot-to-lot Consistency, Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group randomly and equally assigned to three different batches of MCV4 for single-dose vaccination.

Being tested
batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4), batch 2 of MCV4, batch 3 of MCV4, Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Keywords
Vaccine, Positive controlled, Immunogenicity, Safety, 18-55 years
Medical subject headings
Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4)Biological

    Also called Menhycia

    1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

  • batch 2 of MCV4Biological

    Also called Menhycia

    1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

  • batch 3 of MCV4Biological

    Also called Menhycia

    1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

  • Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological

    Also called Menactra

    1 dose of Menactra (0.5ml) on Day 0, Intramuscular injection

Study groups in NCT06131554
Study groupRoleWhat they receive
batch 1 of MCV4Experimental1 dose of Menhycia on Day 0
Receives: Biological: batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4)
batch 2 of MCV4Experimental1 dose of Menhycia on Day 0
Receives: Biological: batch 2 of MCV4
batch 3 of MCV4Experimental1 dose of Menhycia on Day 0
Receives: Biological: batch 3 of MCV4
Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineActive comparator1 dose of Menactra on Day 0
Receives: Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The geometric mean titer (GMT) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants.

    Measured: Day 30 post vaccination

  2. The seroconversion rate of serogroup A, C, Y, and W135 meningococcal rSBA titer.

    Measured: Day 30 post vaccination

  3. The incidence of adverse reactions (ARs) in all participants.

    Measured: Within 7 days post vaccination

Secondary outcomes (8)

  1. The geometric mean fold increase (GMI) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants.

    Measured: Day 30 post vaccination

  2. The proportion of GMT ≥ 1:128 of serogroup A, C, Y and W135 meningococcal rSBA titer on day 30 post vaccination in all participants.

    Measured: Day 30 post vaccination

  3. The incidence of ARs and adverse events (AEs) in all participants.

    Measured: Within 30 days post vaccination

  4. The incidence of ARs in all participants.

    Measured: Within 30 min post vaccination

  5. The incidence of serious adverse events (SAEs) in all participants.

    Measured: Within 365 days post vaccination

  6. The GMT of serogroup A, C, Y and W135 meningococcal antibodies in the 480 subjects (120 of each subgroup,Immunopersistence group)

    Measured: Day 90, day 180 and day 365 post vaccination

  7. The GMI of serogroup A, C, Y and W135 meningococcal antibodies in the 480 subjects (120 of each subgroup,Immunopersistence group).

    Measured: Day 90, day 180 and day 365 post vaccination

  8. The proportion of GMT ≥ 1:128 of serogroup A, C, Y and W135 meningococcal antibodies in the 480 subjects (120 of each subgroup,Immunopersistence group).

    Measured: Day 90, day 180 and day 365 post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start20 Mar 2024
  3. Primary completion12 Jul 2024
  4. Study completion4 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131554
Sponsor's protocol ID
CTP-MCVF-006
Status last verified
Aug 2026
First submitted
9 Nov 2023
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4), batch 2 of MCV4 and batch 3 of MCV4 in people with Meningococcal Meningitis, run by CanSino Biologics Inc. at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The geometric mean titer (GMT) of serogroup A, C, Y and W135 meningococcal rSBA titer in all participants. (time frame: Day 30 post vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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