MeningococcalPhase 1NCT02867319

Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old

A Phase 1 study testing A dose of ACYW135 meningococcal polysaccharide vaccine in people with Meningococcal, run by Beijing Chaoyang District Centre for Disease Control and Prevention.

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 phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and active surveillance. Read more about this study

Who is it for?: Ages 2 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal
What is being tested?: A dose of ACYW135 meningococcal polysaccharide vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Mar 2016to Jul 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 to 50 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

With the subject (or his guardian's) informed consent and signed the informed consent;
The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
The Subject or his guardian could comply with the clinical study protocol;
Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
Have not been inoculated with other preventive biological products;
Axillary temperature≤37.0 ℃.

Who cannot join

Children with the history of Neisseria meningitis;
Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
Have been accepted blood products in the past 3 months;
Have been inoculated with other research drugs or vaccines in the past month;
Have been inoculated with attenuated live vaccine in the past 14 days;

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Have been inoculated with subunit or inactivated vaccine in the past 7 days;
Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
Had fever in the past 3 days (axillary temperature≥38.0℃) ;
Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
Asplenia, functional asplenia and asplenia or splenectomy of any situation;
Had epilepsy, convulsions, encephalopathy, mental illness or family history;
Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
The female during her pregnant and lactation period or who plan to become pregnant during the trial.
The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.

About this study

This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and active surveillance.

Conditions: Meningococcal
Being tested: A dose of ACYW135 meningococcal polysaccharide vaccine
Keywords: safety, vaccine

What participants receive

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

A dose of ACYW135 meningococcal polysaccharide vaccineBiological
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.

Study groups in NCT02867319
Study group	Role	What they receive
age of 18-50 years old	Experimental	Not described Receives: Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
age of 7-17 years old	Experimental	Not described Receives: Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
age of 2-6 years old	Experimental	Not described Receives: Biological: A dose of ACYW135 meningococcal polysaccharide vaccine

What is being measured

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

The rate of adverse reactions of ACYW135 meningococcal polysaccharide vaccine
Adverse reactions associated with vaccine will be observed in subjects after each vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
Measured: 28 days

Timeline

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

Mar 2016Jul 2016

First posted15 Aug 2016 (estimated)
Study startMar 2016
Primary completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02867319
Sponsor's protocol ID: cycdc2016-3
Status last verified: Aug 2016
First submitted: 11 Aug 2016
Last updated: 16 Aug 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
Active, not recruitingPhase 3
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
Meningococcal Immunisation, Healthy Volunteers
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease

All Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
ClinicalTrials.gov ID: NCT02867319
Acronym / sponsor ID: cycdc2016-3
Conditions: Meningococcal
Keywords: safety, vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
Study start: Mar 2016
Primary completion: Jul 2016 (actual)
First posted: 15 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.

This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and active surveillance.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
age of 18-50 years old	Experimental	Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
age of 7-17 years old	Experimental	Biological: A dose of ACYW135 meningococcal polysaccharide vaccine
age of 2-6 years old	Experimental	Biological: A dose of ACYW135 meningococcal polysaccharide vaccine

Who may qualify

Ages: 2 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

With the subject (or his guardian's) informed consent and signed the informed consent;
The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
The Subject or his guardian could comply with the clinical study protocol;
Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
Have not been inoculated with other preventive biological products;

Key exclusion criteria (17 listed)

Children with the history of Neisseria meningitis;
Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
Have been accepted blood products in the past 3 months;
Have been inoculated with other research drugs or vaccines in the past month;

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
A dose of ACYW135 meningococcal polysaccharide vaccineA dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.	Biological	age of 18-50 years old, age of 2-6 years old, age of 7-17 years old

Primary outcome

The rate of adverse reactions of ACYW135 meningococcal polysaccharide vaccine
Time frame: 28 days
Adverse reactions associated with vaccine will be observed in subjects after each vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.

Related trials for 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
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
Active, not recruitingPhase 3
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
Meningococcal Immunisation, Healthy Volunteers
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing A dose of ACYW135 meningococcal polysaccharide vaccine in people with Meningococcal, run by Beijing Chaoyang District Centre for Disease Control and Prevention.

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 6 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: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

The rate of adverse reactions of ACYW135 meningococcal polysaccharide vaccine (time frame: 28 days). 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 NCT02867319.

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 16 Aug 2016.