Meningococcal MeningitisPhase 1NCT02481232
A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
A Phase 1 study testing freeze-dried group ACYW135 MCV in people with Meningococcal Meningitis, run by Lanzhou Institute of Biological Products Co., Ltd at 1 site in China.
Trial summary
Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old Read more about this study
- Who is it for?
- Ages 2 months to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis
- What is being tested?
- freeze-dried group ACYW135 MCV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 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 2 months to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy infants unimmunized Group A\&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2~11 months-old, and healthy toddler more than 1-year-old without booster immunization.
- The guardian or himself informed consent, and signed the informed consent form;
- The guardian and family agreed to abide by the requirements of clinical trial scheme;
- Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history;
- the axillary temperature < 37.1 ℃;
- 2-months-old group in the age of 61-90 days;
- 7-months-old group in the age of 211-300 days;
- 1-year-old group in age of one full year of life.
Who cannot join
- Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history;
- Neomycin, streptomycin and polymyxin B allergies;
- With immunodeficiency, immunosuppressant therapy;
- History of meningitis;
- Women in lactation or pregnant;
- Acute febrile diseases and infectious diseases;
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- History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients;
- Had a severe allergic reaction of vaccination in the past;
- Took oral steroids more than 14 days in last month;
- Had high fever (axillary temperature≥38.0℃ or higher)in the past three days;
- Prepare to attend or is in any other drug clinical study;
- Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hubei CDC
Wuhan, Hubei, 430079
Faxian Zhan, Manager, 008613908639947, zhanfx@163.com
About this study
Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old
Read the detailed description
There are five different age groups(18~55 years/7~17 years/1~6 years/7~10 months/2 months),each group has 40 people and divided into two subgroups. Each subgroup will inject different vaccine(MCV4 4μg,MCV4 8μg).For 7~10 months\&2 months age groups,there are 2\&3 injection seperately. Each injection interval is 1 months.
After 7 days observation of 1 dose immunization in Group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. After the first dose of 7~10 months group and evaluating safety, 2 months group immunized the first dose. All participants completed the immune procedure, then observed the safety to 30 days after whole immunization.
Data collection: Subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis.
- Conditions
- Meningococcal Meningitis
- Being tested
- freeze-dried group ACYW135 MCV
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
freeze-dried group ACYW135 MCVBiological
Group A, C, Y and W135 Meningococcal conjugate vaccine is suitable for immune prevention of epidemic cerebrospinal meningitis more than 2 months of age population
| Study group | Role | What they receive |
|---|---|---|
| freeze-dried group ACYW135 MCV 4μg | Experimental | 4μg group: vaccines serial number is A0001-A0100（18-55 years-old group A0001-A0020，7-17 years-old group A0021-A0040，1-6 years-old group A0041-A0060，7-10 months-old group A0061-A0080，2 months-old group A0081-A0100） Receives: Biological: freeze-dried group ACYW135 MCV |
| freeze-dried group ACYW135 MCV 8μg | Experimental | 8μg group: vaccines serial number is B0001-B0100（18-55 years-old group B0001-B0020，7-17 years-old group B0021-B0040，1-6 years-old group B0041-B0060，7-10 months-old group B0061-B0080，2 months-old group B0081-B0100） Receives: Biological: freeze-dried group ACYW135 MCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
systemic and local reactions 30 days after full-course vaccination
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal MeningitisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanzhou Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481232
- Sponsor's protocol ID
- MCV4-001
- Status last verified
- Jun 2015
- First submitted
- 23 Jun 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
- ClinicalTrials.gov ID
- NCT02481232
- Acronym / sponsor ID
- MCV4-001
- Conditions
- Meningococcal Meningitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lanzhou Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Air Force Military Medical University, China
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Jun 2015 (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.
Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old
Detailed description
There are five different age groups(18~55 years/7~17 years/1~6 years/7~10 months/2 months),each group has 40 people and divided into two subgroups. Each subgroup will inject different vaccine(MCV4 4μg,MCV4 8μg).For 7~10 months\&2 months age groups,there are 2\&3 injection seperately. Each injection interval is 1 months.
After 7 days observation of 1 dose immunization in Group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. After the first dose of 7~10 months group and evaluating safety, 2 months group immunized the first dose. All participants completed the immune procedure, then observed the safety to 30 days after whole immunization.
Data collection: Subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| freeze-dried group ACYW135 MCV 4μg | Experimental | Biological: freeze-dried group ACYW135 MCV4μg group: vaccines serial number is A0001-A0100（18-55 years-old group A0001-A0020，7-17 years-old group A0021-A0040，1-6 years-old group A0041-A0060，7-10 months-old group A0061-A0080，2 months-old group A0081-A0100） |
| freeze-dried group ACYW135 MCV 8μg | Experimental | Biological: freeze-dried group ACYW135 MCV8μg group: vaccines serial number is B0001-B0100（18-55 years-old group B0001-B0020，7-17 years-old group B0021-B0040，1-6 years-old group B0041-B0060，7-10 months-old group B0061-B0080，2 months-old group B0081-B0100） |
Who may qualify
- Ages
- 2 months to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Healthy infants unimmunized Group A\&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2~11 months-old, and healthy toddler more than 1-year-old without booster immunization.
- The guardian or himself informed consent, and signed the informed consent form;
- The guardian and family agreed to abide by the requirements of clinical trial scheme;
- Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history;
- the axillary temperature < 37.1 ℃;
Key exclusion criteria (12 listed)
- Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history;
- Neomycin, streptomycin and polymyxin B allergies;
- With immunodeficiency, immunosuppressant therapy;
- History of meningitis;
- Women in lactation or pregnant;
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 |
|---|---|---|
| freeze-dried group ACYW135 MCVGroup A, C, Y and W135 Meningococcal conjugate vaccine is suitable for immune prevention of epidemic cerebrospinal meningitis more than 2 months of age population | Biological | freeze-dried group ACYW135 MCV 4μg, freeze-dried group ACYW135 MCV 8μg |
Primary outcome
systemic and local reactions 30 days after full-course vaccination
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
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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.
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 freeze-dried group ACYW135 MCV in people with Meningococcal Meningitis, run by Lanzhou Institute of Biological Products 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 8 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 25 Jun 2015. 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?
Contact Zhiqiang Zhao, Manager (008613919133537, matinzhao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systemic and local reactions 30 days after full-course vaccination (time frame: 30 days). 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 25 Jun 2015.