Meningococcal InfectionsPhase 1NCT04236960
Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
A Phase 1 study testing Meningococcal Group ACYW135 Conjugate Vaccine in people with Meningococcal Infections, run by Walvax Biotechnology Co., Ltd. at 1 site in China.
Trial summary
A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years 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 Infections
- What is being tested?
- Meningococcal Group ACYW135 Conjugate Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2018to 28 Nov 2019
- 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 children, adolescents and adults (age range: 2 months to 55 years old) based on medical history, physical examination or judgement of the investigator
- Subjects aged ≥18 years old voluntarily agree to participate in this clinical study and sign the informed consent form; or for subjects aged <18 years old, the legal guardian voluntarily agrees that his/her child to participate in this clinical study, and sign the informed consent form. For juveniles aged ≥8 years old, both the subject and his/her legal guardians should voluntarily agree to participate in this clinical study and sign the informed consent form.
- The subject and his/her legal guardians as well as the family members are able to follow the request of clinical study protocol.
- Subjects aged 2 or 3 months should have no vaccination history of any meningococcal vaccine; subjects aged 7~23 months should have not received any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in National Immunization Program, and the time since last vaccination of meningococcal group A polysaccharide vaccine should be >6 months; for subjects ≥2 years, the time since last vaccination of meningococcal vaccine should be >2 years.
- For subjects aged ≥2 years, there should be no clinically significant abnormal hematology, liver and renal function results judged by the investigator before immunization.
- Subjects should not receive any attenuated live vaccine 14 days, or inactivated vaccine 7 days before or after vaccination.
- Axillary temperature ≤37.0℃.
Who cannot join
- Subjects aged 2 or 3 months at enrollment with birth weight <2.5 kg.
- Subjects aged 2 or 3 months at enrollment had received blood products and immunoglobin after birth; subjects of other age groups had received blood products or immunoglobin in <3 months before vaccination.
- Subjects aged <12 months at enrollment are diagnosed as with pathological jaundice or have a history of pathological jaundice.
- Subjects aged <2 months at enrollment had abnormal labor (dystocia, assisted instrumental delivery) or with the history of asphyxia or nervous damage.
- Subjects aged ≥18 years who are planning pregnancy, or are pregnant, or are breastfeeding.
- Subjects aged ≥18 years with uncontrollable hypertension (during screening: systolic BP >140 mmHg or diastolic BP >90 mmHg).
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- Subjects are known to be allergic to certain components contained in the investigational vaccine (mainly include: capsular polysaccharide of meningococcal group A, group C, group Y, or group W135, diphtheria toxoid or diphtheria antigen).
- Subjects with the history of serious allergy to any vaccine or drug. (including but not limited to: allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction [Arthus reaction]).
- Subjects with the history of meningitis.
- Subjects with moderate to severe fever (axillary temperature ≥38.0℃) in last 3 days.
- Subjects with the history or family history of convulsion, seizure, encephalopathy, or psychiatric disorders.
- Subjects with definite diagnosis of thrombocytopenia or other coagulation disorders.
- Subjects with primary or secondary immunological dysfunction, including HIV infection, disorder or resection of thyroid, pancreas, liver, spleen or kidney; or needed treatment due to thyroid disorders in last 12 months (time interval <12 months).
- Subjects have received immunosuppressive therapy, cytotoxic therapy, corticosteroid hormone (not include corticosteroid hormone spray for allergic rhinitis, epithelial corticosteroid hormone for acute and non-complicated dermatitis) in last 6 months (time interval <6 months).
- Subjects with known congenital malformation, developmental disabilities or clinically confirmed serious chronic diseases (e.g., Down syndrome, diabetes mellitus, sickle cell anemia or nervous disease, Guillain-Barre syndrome, etc.).
- Subjects with known or suspected diseases that are likely to affect the vaccination by investigators' judgement, such as: serious respiratory diseases, acute infection or the active period of chronic disease, serious cardiovascular diseases, liver and renal diseases, malignant tumors, serious infectious or allergic skin diseases.
- Subjects are participating or plan to participate in other clinical trials of investigational medications.
- Any other conditions that may influence the evaluation of clinical study by investigators' judgement.
- New conditions that conforms with the exclusion criteria for first dose.
- Subjects that develop grade 4 adverse reactions after vaccination of investigational vaccine.
- Subjects that develop serious allergic reactions after vaccination of investigational vaccine.
- Any other conditions that may influence the evaluation of clinical study by investigators' judgement based on the exclusion criteria for first dose.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Center for Disease Control and Prevention
Guangzhou, Guangdong
About this study
Official title: Phase I Clinical Study of Meningococcal Group ACYW135 Conjugate Vaccine
A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years old.
- Conditions
- Meningococcal Infections
- Being tested
- Meningococcal Group ACYW135 Conjugate Vaccine
- Keywords
- Meningitis, Meningococcal, Serogroup A, Meningitis, Meningococcal, Serogroup C, Meningitis, Meningococcal, Serogroup Y, Meningitis, Meningococcal, Serogroup W135
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Group ACYW135 Conjugate VaccineBiological
1 dose in Stage 1 (2~55 yrs), 2 doses in Stage 2 (7~23 mos), and 3 doses in Stage 3 (2\&3 mos)
| Study group | Role | What they receive |
|---|---|---|
| 18~55 yrs | Experimental | 1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0. Receives: Biological: Meningococcal Group ACYW135 Conjugate Vaccine |
| 2~17 yrs | Experimental | 1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0. Receives: Biological: Meningococcal Group ACYW135 Conjugate Vaccine |
| 7~23 mos | Experimental | 2 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between the first and second dose. Receives: Biological: Meningococcal Group ACYW135 Conjugate Vaccine |
| 3 mos | Experimental | 3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between every two doses. Receives: Biological: Meningococcal Group ACYW135 Conjugate Vaccine |
| 2 mos | Experimental | 3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. Two-month interval between every two doses. Receives: Biological: Meningococcal Group ACYW135 Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events after each vaccination
Percentage of subjects with local and systemic adverse events after each dose of vaccination
Measured: 30 days after vaccination
Secondary outcomes (4)
Incidence of serious adverse events after vaccination
Percentage of subjects with serious adverse events from day 0 to 6 months after last dose
Measured: day 0 to 6 months after last dose
Blood routine in 2 years and above subjects
content of hemoglobin（g/dL）、white blood cell count（WBC）、blood platelet count（PLT）3 days after vaccination in 2 years and above subjects
Measured: 3 days after vaccination
Liver function in 2 years and above subjects
Alanine aminotransferase（ALT），Aspartate aminotransferase（AST），Total bilirubin(TBIL) 3 days after vaccination in 2 years and above subjects
Measured: 3 days after vaccination
Renal function in 2 years and above subjects
Creatinine（CR），Urea nitrogen（BUN）3 days after vaccination in 2 years and above subjects
Measured: 3 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start17 Jul 2018
- Primary completion16 Sep 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal InfectionsStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walvax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236960
- Sponsor's protocol ID
- 008152017002
- Status last verified
- Jan 2020
- First submitted
- 5 Jul 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of Meningococcal Group ACYW135 Conjugate Vaccine
- ClinicalTrials.gov ID
- NCT04236960
- Acronym / sponsor ID
- 008152017002
- Conditions
- Meningococcal Infections
- Keywords
- Meningitis, Meningococcal, Serogroup A, Meningitis, Meningococcal, Serogroup C, Meningitis, Meningococcal, Serogroup Y, Meningitis, Meningococcal, Serogroup W135
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Walvax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 22 Jan 2020 (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.
A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 18~55 yrs | Experimental | Biological: Meningococcal Group ACYW135 Conjugate Vaccine1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0. |
| 2~17 yrs | Experimental | Biological: Meningococcal Group ACYW135 Conjugate Vaccine1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0. |
| 7~23 mos | Experimental | Biological: Meningococcal Group ACYW135 Conjugate Vaccine2 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between the first and second dose. |
| 3 mos | Experimental | Biological: Meningococcal Group ACYW135 Conjugate Vaccine3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between every two doses. |
| 2 mos | Experimental | Biological: Meningococcal Group ACYW135 Conjugate Vaccine3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. Two-month interval between every two doses. |
Who may qualify
- Ages
- 2 months to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy children, adolescents and adults (age range: 2 months to 55 years old) based on medical history, physical examination or judgement of the investigator
- Subjects aged ≥18 years old voluntarily agree to participate in this clinical study and sign the informed consent form; or for subjects aged <18 years old, the legal guardian voluntarily agrees that his/her child to participate in this clinical study, and sign the informed consent form. For juveniles aged ≥8 years old, both the subject and his/her legal guardians should voluntarily agree to participate in this clinical study and sign the informed consent form.
- The subject and his/her legal guardians as well as the family members are able to follow the request of clinical study protocol.
- Subjects aged 2 or 3 months should have no vaccination history of any meningococcal vaccine; subjects aged 7~23 months should have not received any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in National Immunization Program, and the time since last vaccination of meningococcal group A polysaccharide vaccine should be >6 months; for subjects ≥2 years, the time since last vaccination of meningococcal vaccine should be >2 years.
- For subjects aged ≥2 years, there should be no clinically significant abnormal hematology, liver and renal function results judged by the investigator before immunization.
Key exclusion criteria (22 listed)
- Subjects aged 2 or 3 months at enrollment with birth weight <2.5 kg.
- Subjects aged 2 or 3 months at enrollment had received blood products and immunoglobin after birth; subjects of other age groups had received blood products or immunoglobin in <3 months before vaccination.
- Subjects aged <12 months at enrollment are diagnosed as with pathological jaundice or have a history of pathological jaundice.
- Subjects aged <2 months at enrollment had abnormal labor (dystocia, assisted instrumental delivery) or with the history of asphyxia or nervous damage.
- Subjects aged ≥18 years who are planning pregnancy, or are pregnant, or are breastfeeding.
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 Group ACYW135 Conjugate Vaccine1 dose in Stage 1 (2~55 yrs), 2 doses in Stage 2 (7~23 mos), and 3 doses in Stage 3 (2\&3 mos) | Biological | 18~55 yrs, 2 mos, 2~17 yrs, 3 mos, 7~23 mos |
Primary outcome
Incidence of adverse events after each vaccination
Time frame: 30 days after vaccination
Percentage of subjects with local and systemic adverse events after each dose of vaccination
4 secondary outcomes
Incidence of serious adverse events after vaccination
Time frame: day 0 to 6 months after last dose
Blood routine in 2 years and above subjects
Time frame: 3 days after vaccination
Liver function in 2 years and above subjects
Time frame: 3 days after vaccination
Renal function in 2 years and above subjects
Time frame: 3 days after vaccination
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 22 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Group ACYW135 Conjugate Vaccine in people with Meningococcal Infections, run by Walvax Biotechnology 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 7 inclusion and 22 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 22 Jan 2020. 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?
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?
Incidence of adverse events after each vaccination (time frame: 30 days after 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 22 Jan 2020.