- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236960
Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
January 16, 2020 updated by: Walvax Biotechnology Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China
- Guangdong Provincial Center for Disease Control and Prevention
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 55 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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℃.
Exclusion Criteria for First Dose:
- 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).
- 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.
Exclusion Criteria for Second and Third Dose:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18~55 yrs
1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.
|
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)
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Experimental: 2~17 yrs
1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.
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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)
|
Experimental: 7~23 mos
2 doses of meningococcal group ACYW135 conjugate vaccine will be administered.
One-month interval between the first and second dose.
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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)
|
Experimental: 3 mos
3 doses of meningococcal group ACYW135 conjugate vaccine will be administered.
One-month interval between every two doses.
|
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)
|
Experimental: 2 mos
3 doses of meningococcal group ACYW135 conjugate vaccine will be administered.
Two-month interval between every two doses.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events after each vaccination
Time Frame: 30 days after vaccination
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Percentage of subjects with local and systemic adverse events after each dose of vaccination
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30 days after vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of serious adverse events after vaccination
Time Frame: day 0 to 6 months after last dose
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Percentage of subjects with serious adverse events from day 0 to 6 months after last dose
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day 0 to 6 months after last dose
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Blood routine in 2 years and above subjects
Time Frame: 3 days after vaccination
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content of hemoglobin(g/dL)、white blood cell count(WBC)、blood platelet count(PLT)3 days after vaccination in 2 years and above subjects
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3 days after vaccination
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Liver function in 2 years and above subjects
Time Frame: 3 days after vaccination
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Alanine aminotransferase(ALT),Aspartate aminotransferase(AST),Total bilirubin(TBIL) 3 days after vaccination in 2 years and above subjects
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3 days after vaccination
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Renal function in 2 years and above subjects
Time Frame: 3 days after vaccination
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Creatinine(CR),Urea nitrogen(BUN)3 days after vaccination in 2 years and above subjects
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3 days after vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2018
Primary Completion (Actual)
September 16, 2019
Study Completion (Actual)
November 28, 2019
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
January 16, 2020
First Posted (Actual)
January 22, 2020
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 16, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 008152017002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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