Meningococcal Infections
Conditions
Keywords
Meningitis, Meningococcal, Serogroup A, Meningitis, Meningococcal, Serogroup C, Meningitis, Meningococcal, Serogroup Y, Meningitis, Meningococcal, Serogroup W135
Brief 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.
Interventions
BIOLOGICALMeningococcal Group ACYW135 Conjugate Vaccine
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)
Sponsors
Walvax Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events after each vaccination | 30 days after vaccination | Percentage of subjects with local and systemic adverse events after each dose of vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse events after vaccination | day 0 to 6 months after last dose | Percentage of subjects with serious adverse events from day 0 to 6 months after last dose |
| Blood routine in 2 years and above subjects | 3 days after vaccination | content of hemoglobin（g/dL）、white blood cell count（WBC）、blood platelet count（PLT）3 days after vaccination in 2 years and above subjects |
| Liver function in 2 years and above subjects | 3 days after vaccination | Alanine aminotransferase（ALT），Aspartate aminotransferase（AST），Total bilirubin(TBIL) 3 days after vaccination in 2 years and above subjects |
| Renal function in 2 years and above subjects | 3 days after vaccination | Creatinine（CR），Urea nitrogen（BUN）3 days after vaccination in 2 years and above subjects |
Countries
China
Outcome results
None listed