Meningitis, MeningococcalPhase 3NCT05252715
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months
A Phase 3 study testing Meningococcal ACYW135 Polysaccharide Conjugate Vaccine and Meningococcal A and C Polysaccharide Conjugate Vaccine in people with Meningitis, Meningococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months. Read more about this study
- Who is it for?
- Ages 3 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Meningococcal ACYW135 Polysaccharide Conjugate Vaccine and Meningococcal A and C Polysaccharide Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesChina
- Study dates
- 18 Dec 2021to 18 Sep 2024
- 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 3 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For primary vaccination
- Subjects aged 3-5 months;
- Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
- Axillary body temperature ≤ 37.0 ℃;
- The guardian signs the informed consent form;
- The guardian and his family agree to comply with the requirements of the clinical trial protocol;
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- Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine at the aged of 3-5 months;
- Subjects who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
- For booster vaccination
- Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
- The guardian and his family agree to comply with the requirements of the clinical trial protocol.
Who cannot join
- For primary vaccination
- Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
- History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
- A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
- History of Abnormal production process, asphyxia rescue, or congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
- Have been diagnosed as infectious diseases, such as tuberculosis, viral hepatitis or their parents infected with human immunodeficiency virus (HIV);
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- Have progressive nervous system diseases such as encephalopathy, epilepsy, convulsions or related family history;
- History of acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) or take antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) in the past 3 days;
- History of using illegal drugs (receiving systemic corticosteroid treatment≥2mg/kg/day through any route of administration, and using ≥14 days, such as prednisone, inhaled hormone budesonide, fluticasone, etc., or receiving other immunosuppressants, such as cyclophosphamide, etc.);
- History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
- Plan to participate or be participating in any other drug clinical research;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
- For booster vaccination
- The subjects were vaccinated with any meningococcal vaccine after primary immunization and before blood collection of booster immunization;
- The subjects have been known or suspected to have immunological defects since participating in this clinical trial, including being treated with immunosuppressants (such as chemotherapy, corticosteroids, antimetabolics, cytotoxic drugs, etc.) and HIV infection;
- History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before booster immunization;
- According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Liujiang Center for Disease Control and Prevention
Liuzhou, Guangxi
Binyang Center for Disease Control and Prevention
Nanning, Guangxi
About this study
Official title: A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 5 Months
The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months.
- Conditions
- Meningitis, Meningococcal
- Being tested
- Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, Meningococcal A and C Polysaccharide Conjugate 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.
Meningococcal ACYW135 Polysaccharide Conjugate VaccineBiological
Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 meningococcal polysaccharide combined with tetanus toxoid.
Meningococcal A and C Polysaccharide Conjugate VaccineBiological
Single intramuscular dose contains 10 µg each of Serogroup A and C meningococcal polysaccharide combined with tetanus toxoid.
| Study group | Role | What they receive |
|---|---|---|
| Meningococcal ACYW135 Polysaccharide Conjugate Vaccine | Experimental | Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively. Booster vaccination at 18 months of age. Receives: Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine |
| Meningococcal A and C Polysaccharide Conjugate Vaccine | Active comparator | Meningococcal A and C Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively. Receives: Biological: Meningococcal A and C Polysaccharide Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate
Measured: 30 day after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start18 Dec 2021
- Primary completion22 Aug 2023
- Study completion18 Sep 2024 (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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252715
- Sponsor's protocol ID
- 2020040C-1
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 5 Months
- ClinicalTrials.gov ID
- NCT05252715
- Acronym / sponsor ID
- 2020040C-1
- Conditions
- Meningitis, Meningococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 18 Sep 2024 (estimated)
- First posted
- 23 Feb 2022 (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.
The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months.
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 |
|---|---|---|
| Meningococcal ACYW135 Polysaccharide Conjugate Vaccine | Experimental | Biological: Meningococcal ACYW135 Polysaccharide Conjugate VaccineMeningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively. Booster vaccination at 18 months of age. |
| Meningococcal A and C Polysaccharide Conjugate Vaccine | Active comparator | Biological: Meningococcal A and C Polysaccharide Conjugate VaccineMeningococcal A and C Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively. |
Who may qualify
- Ages
- 3 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- For primary vaccination
- Subjects aged 3-5 months;
- Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
- Axillary body temperature ≤ 37.0 ℃;
- The guardian signs the informed consent form;
Key exclusion criteria (17 listed)
- For primary vaccination
- Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
- History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
- A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
- History of Abnormal production process, asphyxia rescue, or congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
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 |
|---|---|---|
| Meningococcal ACYW135 Polysaccharide Conjugate VaccineSingle intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 meningococcal polysaccharide combined with tetanus toxoid. | Biological | Meningococcal ACYW135 Polysaccharide Conjugate Vaccine |
| Meningococcal A and C Polysaccharide Conjugate VaccineSingle intramuscular dose contains 10 µg each of Serogroup A and C meningococcal polysaccharide combined with tetanus toxoid. | Biological | Meningococcal A and C Polysaccharide Conjugate Vaccine |
Primary outcome
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate
Time frame: 30 day after each vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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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.
Lin Du study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal ACYW135 Polysaccharide Conjugate Vaccine and Meningococcal A and C Polysaccharide Conjugate Vaccine in people with Meningitis, Meningococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 2 sites 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 11 inclusion and 17 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate (time frame: 30 day after each 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 4 Apr 2024.