Meningitis, MeningococcalPhase 3NCT04689165
A Phase III Clinical Trial of the Group A Meningococcal Polysaccharide Vaccine
A Phase 3 study testing Experimental Group A meningococcal polysaccharide vaccine in people with Meningitis, Meningococcal, run by Wei Cun at 1 site in China.
Trial summary
This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 6-15 months. Read more about this study
- Who is it for?
- Ages 6 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Experimental Group A 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
- 14 Sep 2020to Dec 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 6 months 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 3 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 infants aged 6 to 15 months.
- 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 infants aged 6 to 15 months.
- 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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- Participants 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.
- 3-17 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 and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
- Immunization with any vaccine within 30 days.
- 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.
- Women with positive pregnancy test after menarche.
- Any other situations judged by investigators as not suitable for participating in this study.
- 6-15 months 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.
- Preterm birth at birth (before 37th week of pregnancy) or low birth weight (birth weight < 2300g for girls and < 2500g for boys);
- 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 meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
- Preterm birth at birth (before 37th week of pregnancy) or low birth weight (birth weight < 2300g for girls and < 2500g for boys);
- 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, 1 recruiting
- Recruiting
Yunnan Center for Disease Control and Prevention
Kunming, Yunnan
Wei Cun, Doctor, +86-13629464497, cunwei@foxmail.com
About this study
Official title: A Randomized, Double-Blind, Controlled, Non-inferiority Phase III Trial of a Group A Meningococcal Polysaccharide Vaccine in Healthy Infants Aged 6-15 Months
This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 6-15 months.
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 3-17 years, and 40 subjects aged 6-15 months. The second phase was a randomized, double-blind, controlled, non-inferiority phase III clinical trial in 1200 healthy infants aged 6-15 months, to evaluate the immunogenicity and safety of the experimental vaccine after two doses of immunization.
- Conditions
- Meningitis, Meningococcal
- Being tested
- Experimental Group A meningococcal polysaccharide vaccine, Control Group A 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 meningococcal polysaccharide vaccineBiological
Two doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
Control Group A meningococcal polysaccharide vaccineBiological
Two doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
| Study group | Role | What they receive |
|---|---|---|
| Experimental Vaccine | Experimental | Two doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12 Receives: Biological: Experimental Group A meningococcal polysaccharide vaccine |
| Active Comparator Vaccine | Active comparator | Two doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12 Receives: Biological: Control Group A meningococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after the second vaccination
Measured: 28 days after the second vaccination
Secondary outcomes (4)
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 7 days after vaccination
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 28 days after vaccination
Serious adverse events
Occurence of Serious adverse events after vaccination
Measured: 6 months after the second vaccination
GMT
GMT of Group A 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.
- First posted30 Dec 2020
- Study start14 Sep 2020
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, MeningococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Cun
- Collaborators
- Yunnan Center for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Wei Cun, Chinese Academy of Medical Sciences
- Investigators
- Yan Zheng, Master, Principal investigator, Yunnan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689165
- Sponsor's protocol ID
- 20190701
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled, Non-inferiority Phase III Trial of a Group A Meningococcal Polysaccharide Vaccine in Healthy Infants Aged 6-15 Months
- ClinicalTrials.gov ID
- NCT04689165
- Acronym / sponsor ID
- 20190701
- Conditions
- Meningitis, Meningococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- Wei Cun
- Collaborators
- Yunnan Center for Disease Control and Prevention
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 6-15 months.
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 3-17 years, and 40 subjects aged 6-15 months. The second phase was a randomized, double-blind, controlled, non-inferiority phase III clinical trial in 1200 healthy infants aged 6-15 months, to evaluate the immunogenicity and safety of the experimental vaccine after two doses of immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Vaccine | Experimental | Biological: Experimental Group A meningococcal polysaccharide vaccineTwo doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12 |
| Active Comparator Vaccine | Active comparator | Biological: Control Group A meningococcal polysaccharide vaccineTwo doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12 |
Who may qualify
- Ages
- 6 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
Key exclusion criteria (65 listed)
- 3-17 years group:
- 6-15 months group:
- The Second stage study (A phase III clinical trial )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Group A meningococcal polysaccharide vaccineTwo doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12 | Biological | Experimental Vaccine |
| Control Group A meningococcal polysaccharide vaccineTwo doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12 | Biological | Active Comparator Vaccine |
Primary outcome
Seroconversion rate
Time frame: 28 days after the second vaccination
Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after the second vaccination
4 secondary outcomes
Adverse reactions/events rate
Time frame: 7 days after vaccination
Adverse reactions/events rate
Time frame: 28 days after vaccination
Serious adverse events
Time frame: 6 months after the second vaccination
GMT
Time frame: 28 days after the second vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Zheng, Master principal investigator
Yunnan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental Group A meningococcal polysaccharide vaccine in people with Meningitis, Meningococcal, run by Wei Cun 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: status not confirmed, as of the sponsor's last update on 30 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Cun, Doctor (+86-13629464497, cunwei@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (time frame: 28 days after the second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2020.