Meningitis, MeningococcalPhase 1NCT02878291
Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
A Phase 1 study testing Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in people with Meningitis, Meningococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2016
- Phase
- Phase 1
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 3-11 months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.
- Subject or legal representative who consent and has signed written informed consent.
- Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- Subject and parent/guardian who is able to comply with all study procedures.
- Axillary temperature ≤37.0 ℃.
Who cannot join
- History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- Allergic history after vaccination.
- History of meningitis infection disease.
- Acute Febrile illness and Infectious Diseases.
- Febrile illness (temperature ≥ 38°C) in the 3 days.
- Immunodeficiency diseases patients who administered with immunosuppressive agents.
Show all 12Show fewer
- Children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease.
- Liver and kidney or cardiopulmonary disease，acute hypertension and diabetes.
- In pregnancy or lactation or pregnant women.
- Subject who plan to participate in or is in any other drug clinical trial.
- Meningococcal vaccine contraindication.
- Any condition that, in the judgment of investigator, may affect trial assessment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sanjiang Center for Disease Control and Prevention
Sanjiang, Guangxi, 545500
Wu yimei, Bachelor, 86-772-6636680, sjcdcwuyimei@126.com
Yang xu, Bachelor
About this study
Official title: A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months
- Conditions
- Meningitis, Meningococcal
- Being tested
- Meningococcal ACYW135 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
Also called Menwaycon
Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.
Meningococcal ACYW135 Polysaccharide Conjugate VaccineBiological
Also called Menwaycon
Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.
| Study group | Role | What they receive |
|---|---|---|
| High dose Group | Experimental | Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose Receives: Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine |
| low dose Group | Experimental | Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose Receives: Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events during a 30 day follow-up period after each vaccination
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 posted25 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangxi Center for Disease Control and Prevention, Sanjiang Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Du lin, Master, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878291
- Sponsor's protocol ID
- 201518603
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
- ClinicalTrials.gov ID
- NCT02878291
- Acronym / sponsor ID
- 201518603
- Conditions
- Meningitis, Meningococcal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Guangxi Center for Disease Control and Prevention, Sanjiang Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- 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 safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Group | Experimental | Biological: Meningococcal ACYW135 Polysaccharide Conjugate VaccineReceived Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose |
| low dose Group | Experimental | Biological: Meningococcal ACYW135 Polysaccharide Conjugate VaccineReceived Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 3-11 months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.
- Subject or legal representative who consent and has signed written informed consent.
- Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- Subject and parent/guardian who is able to comply with all study procedures.
- Axillary temperature ≤37.0 ℃.
Key exclusion criteria (12 listed)
- History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- Allergic history after vaccination.
- History of meningitis infection disease.
- Acute Febrile illness and Infectious Diseases.
- Febrile illness (temperature ≥ 38°C) in the 3 days.
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 VaccineAlso: MenwayconGroup 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids. | Biological | High dose Group |
| Meningococcal ACYW135 Polysaccharide Conjugate VaccineAlso: MenwayconGroup 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids. | Biological | low dose Group |
Primary outcome
Occurrence of adverse events during a 30 day follow-up period after each vaccination
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 26 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Meningitis, Meningococcal
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
Epidemic Meningitis, Meningococcal Vaccines
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.
Du lin, Master study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in people with Meningitis, Meningococcal, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd 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 5 inclusion and 12 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 26 Aug 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events during a 30 day follow-up period after each vaccination (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 26 Aug 2016.