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Meningitis, MeningococcalPhase 3NCT04689191

A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine

A Phase 3 study testing Experimental Group A and C meningococcal polysaccharide vaccine in people with Meningitis, Meningococcal, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

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 study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A and C meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 2-6 years. Read more about this study

Who is it for?
Ages 2 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Meningitis, Meningococcal
What is being tested?
Experimental Group A and C meningococcal polysaccharide vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,280 participants
Where
1 siteChina
Study dates
15 Sep 2020to 26 Sep 2021
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 2 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy adults aged 18 to 50 years.
  • Proven legal identity.
  • Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
  • Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
  • Axillary temperature ≤37.0℃.
  • Healthy volunteer aged 7 to 17 years.
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  • Proven legal identity.
  • Participants and their legal guardians should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
  • Participants and their legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial.
  • Axillary temperature ≤37.0℃.
  • Healthy children aged 2 to 6 years.
  • Proven legal identity.
  • Participants' legal guardians should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
  • Participants' legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial.
  • Axillary temperature ≤37.0℃.
  • Healthy children aged 2 to 6 years.
  • Proven legal identity.
  • Participants' legal guardians should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
  • Participants' legal guardians should be able to communicate well with investigators, understand and comply with the requirements of this trial.
  • Axillary temperature ≤37.0℃.

Who cannot join

  • Contraindications for vaccination.
  • History of allergy to vaccines or drugs.
  • History of Epidemic Cerebrospinal Meningitis.
  • Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
  • Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
  • Immunization with any vaccine within 30 days.
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  • Patients with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
  • History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
  • Those who developed acute disease or acute attack of chronic disease.
  • Surgical removal of spleen or other important organs for any reason.
  • History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
  • Blood products such as immunoglobulin were received within 30 days before vaccination.
  • Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
  • Those who participated in other clinical studies.
  • Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 12 months after the second vaccination.
  • Any other situations judged by investigators as not suitable for participating in this study.
  • 7-17 years group:
  • Contraindications for vaccination.
  • History of allergy to vaccines or drugs.
  • History of Epidemic Cerebrospinal Meningitis.
  • Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
  • Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
  • Immunization with any vaccine within 30 days.
  • Patients with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
  • Participant who has congenital heart disease, congenital malformation, Down's syndrome, sickle cell anemia or severe diseases with previous clinical manifestations that need to be excluded, including but not limited to nervous system, genetic defect disease (such as faba bean disease), cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system diseases, and History of malignant tumor.
  • Those who developed acute disease or acute attack of chronic disease.
  • Surgical removal of spleen or other important organs for any reason.
  • History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
  • Blood products such as immunoglobulin were received within 30 days before vaccination.
  • Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
  • Those who participated in other clinical studies.
  • Women with positive pregnancy test after menarche.
  • Any other situations judged by investigators as not suitable for participating in this study.
  • 2-6 years group:
  • Contraindications for vaccination.
  • History of allergy to vaccines or drugs.
  • History of Epidemic Cerebrospinal Meningitis.
  • Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine.
  • Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
  • They were vaccinated with live attenuated vaccine within 14 days before vaccination and subunit or inactivated vaccine within 7 days (copy of vaccination certificate of subjects);
  • Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
  • Participant who has congenital heart disease, congenital malformation, Down's syndrome, sickle cell anemia or severe diseases with previous clinical manifestations that need to be excluded, including but not limited to nervous system, genetic defect disease (such as faba bean disease), cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system diseases, and History of malignant tumor.
  • Those who developed acute disease or acute attack of chronic disease.
  • Surgical removal of spleen or other important organs for any reason.
  • History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
  • Blood products such as immunoglobulin were received within 30 days before vaccination.
  • Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
  • Those who participated in other clinical studies.
  • Any other situations judged by investigators as not suitable for participating in this study.
  • The Second stage study (A phase III clinical trial )
  • Contraindications for vaccination.
  • History of allergy to vaccines or drugs.
  • History of Epidemic Cerebrospinal Meningitis.
  • Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine.
  • Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
  • They were vaccinated with live attenuated vaccine within 14 days before vaccination and subunit or inactivated vaccine within 7 days (copy of vaccination certificate of subjects);
  • Participants with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
  • Participant who has congenital heart disease, congenital malformation, Down's syndrome, sickle cell anemia or severe diseases with previous clinical manifestations that need to be excluded, including but not limited to nervous system, genetic defect disease (such as faba bean disease), cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system diseases, and History of malignant tumor.
  • Those who developed acute disease or acute attack of chronic disease.
  • Surgical removal of spleen or other important organs for any reason.
  • History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
  • Blood products such as immunoglobulin were received within 30 days before vaccination.
  • Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
  • Those who participated in other clinical studies.
  • Any other situations judged by investigators as not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Yunnan Center for Disease Control and Prevention

    Kunming, Yunnan

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Controlled, Non-inferiority Phase III Trial of a Group A and C Meningococcal Polysaccharide Vaccine in Healthy Children Aged 2-6 Years

This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A and C meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 2-6 years.

Read the detailed description

This study was divided into two stages. The first stage study was an early safety assessment study among 80 subjects. The first stage study was conducted gradually in 20 subjects aged 18-50 years, 20 subjects aged 7-17 years, and 40 subjects aged 2-6 years. The second phase was a randomized, double-blind, controlled, non-inferiority phase III clinical trial in 1200 healthy infants aged 2-6 years, to evaluate the immunogenicity and safety of the experimantal vaccine after immunization.

Being tested
Experimental Group A and C meningococcal polysaccharide vaccine, Control Group A and C meningococcal polysaccharide vaccine
Medical subject headings
Meningitis, Meningococcal

What participants receive

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

  • Experimental Group A and C meningococcal polysaccharide vaccineBiological

    One dose of Experimental Group A and C meningococcal polysaccharide vaccine

  • Control Group A and C meningococcal polysaccharide vaccineBiological

    One dose of Control Group A and C meningococcal polysaccharide vaccine

Study groups in NCT04689191
Study groupRoleWhat they receive
Experimental VaccineExperimentalOne dose of Experimental Group A and C meningococcal polysaccharide vaccine
Receives: Biological: Experimental Group A and C meningococcal polysaccharide vaccine
Active Comparator VaccineActive comparatorOne dose of Control Group A and C meningococcal polysaccharide vaccine
Receives: Biological: Control Group A and C meningococcal polysaccharide vaccine

What is being measured

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

  1. Seroconversion rate of Group A meningococcal bactericidal antibody

    Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after vaccination

    Measured: 28 days after vaccination

  2. Seroconversion rate of Group C meningococcal bactericidal antibody

    Seroconversion rate of Group C meningococcal bactericidal antibody at day 28 after vaccination

    Measured: 28 days after vaccination

Secondary outcomes (5)

  1. Adverse reactions/events rate

    Occurence of adverse reactions/events after vaccination

    Measured: 7 days after vaccination

  2. Adverse reactions/events rate

    Occurence of adverse reactions/events after vaccination

    Measured: 28 days after vaccination

  3. Serious adverse events

    Occurence of Serious adverse events after vaccination

    Measured: 6 months after the second vaccination

  4. GMT of Group A meningococcal bactericidal antibody

    GMT of Group A meningococcal bactericidal antibody at day 28 after the second vaccination

    Measured: 28 days after the second vaccination

  5. GMT of Group C meningococcal bactericidal antibody

    GMT of Group C meningococcal bactericidal antibody at day 28 after the second vaccination

    Measured: 28 days after the second vaccination

Timeline

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

  1. First posted30 Dec 2020
  2. Study start15 Sep 2020
  3. Primary completion29 Apr 2021
  4. Study completion26 Sep 2021

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
1,280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04689191
Sponsor's protocol ID
20190702
Status last verified
Sep 2026
First submitted
8 Dec 2020
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental Group A and C meningococcal polysaccharide vaccine in people with Meningitis, Meningococcal, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

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 20 inclusion and 65 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 29 Sep 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 China. 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?

Seroconversion rate of Group A meningococcal bactericidal antibody (time frame: 28 days after vaccination). The study lists 2 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 NCT04689191.

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 29 Sep 2026.

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