ACYW135 Meningococcal Polysaccharide VaccinePhase 3NCT02869672
Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
A Phase 3 study testing Tiantan Biology ACYW135 meningococcal polysaccharide vaccine and Hualan Biology ACYW135 meningococcal polysaccharide vaccine in people with ACYW135 Meningococcal Polysaccharide Vaccine, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
Trial summary
This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3 group according to their age, receiving the test vaccine and the control vaccine at the proportion of 1:1 randomly. Read more about this study
- Who is it for?
- Ages 2 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ACYW135 Meningococcal Polysaccharide Vaccine
- What is being tested?
- Tiantan Biology ACYW135 meningococcal polysaccharide vaccine and Hualan Biology ACYW135 meningococcal polysaccharide 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
- No sites listed yet
- Study dates
- Jul 2016to Dec 2016
- 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 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;
Show all 17Show fewer
- 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 study evaluates the safety and immunogenicity of the ACYW135 Meningococcal Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3 group according to their age, receiving the test vaccine and the control vaccine at the proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.
- Being tested
- Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, Hualan Biology ACYW135 meningococcal polysaccharide vaccine
- Keywords
- safety, immunogenicity, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiantan Biology ACYW135 meningococcal polysaccharide vaccineBiological
Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
Hualan Biology ACYW135 meningococcal polysaccharide vaccineBiological
Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| age of 18-50 years old, experimental | Experimental | 0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given. Receives: Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine |
| age of 18-50 years old, control | Active comparator | 0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given. Receives: Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine |
| age of 7-17 years old,experimental | Experimental | 0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given. Receives: Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine |
| age of 7-17 years old, control | Active comparator | 0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given. Receives: Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine |
| age of 2-6 years old,experimental | Experimental | 0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given. Receives: Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine |
| age of 2-6 years old,control | Active comparator | 0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given. Receives: Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
The serum antibody titers will be evaluated at 28 days after vaccination.
Measured: 28 days
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
Adverse reactions associated with vaccine will be observed in subjects after 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.
- First posted17 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACYW135 Meningococcal Polysaccharide VaccineStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869672
- Sponsor's protocol ID
- cycdc2016-5
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
- ClinicalTrials.gov ID
- NCT02869672
- Acronym / sponsor ID
- cycdc2016-5
- Keywords
- safety, immunogenicity, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 17 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 study evaluates the safety and immunogenicity of the ACYW135 Meningococcal Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3 group according to their age, receiving the test vaccine and the control vaccine at the proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| age of 18-50 years old, experimental | Experimental | Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given. |
| age of 18-50 years old, control | Active comparator | Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given. |
| age of 7-17 years old,experimental | Experimental | Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given. |
| age of 7-17 years old, control | Active comparator | Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given. |
| age of 2-6 years old,experimental | Experimental | Biological: Tiantan Biology ACYW135 meningococcal polysaccharide vaccine0.5 ml of Tiantan Biology ACYW135 meningococcal polysaccharide vaccine will be given. |
| age of 2-6 years old,control | Active comparator | Biological: Hualan Biology ACYW135 meningococcal polysaccharide vaccine0.5 ml of Hualan Biology ACYW135 meningococcal polysaccharide vaccine will be given. |
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 |
|---|---|---|
| Tiantan Biology ACYW135 meningococcal polysaccharide vaccineTiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml | Biological | age of 18-50 years old, experimental, age of 2-6 years old,experimental, age of 7-17 years old,experimental |
| Hualan Biology ACYW135 meningococcal polysaccharide vaccineHualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml | Biological | age of 18-50 years old, control, age of 2-6 years old,control, age of 7-17 years old, control |
Primary outcome
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
Time frame: 28 days
The serum antibody titers will be evaluated at 28 days after vaccination.
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
Time frame: 28 days
Adverse reactions associated with vaccine will be observed in subjects after 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
Related trials for ACYW135 Meningococcal Polysaccharide Vaccine
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
Not yet recruitingObservational study
A Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
Epidemic Meningitis
Active, not recruitingPhase 4
Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)
Epidemic Meningitis
Active, not recruitingPhase 3
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds
Meningococcal Meningitis
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 3 study testing Tiantan Biology ACYW135 meningococcal polysaccharide vaccine and Hualan Biology ACYW135 meningococcal polysaccharide vaccine in people with ACYW135 Meningococcal Polysaccharide Vaccine, 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: status not confirmed, as of the sponsor's last update on 18 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 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?
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people. (time frame: 28 days). The study lists 2 primary outcomes in all. 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 18 Aug 2016.