Clinical trial NCT04236960: Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
Official title: Phase I Clinical Study of Meningococcal Group ACYW135 Conjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Meningococcal Infections
Keywords: Meningitis, Meningococcal, Serogroup A
Meningitis, Meningococcal, Serogroup C
Meningitis, Meningococcal, Serogroup Y
Meningitis, Meningococcal, Serogroup W135
Lead sponsor: Walvax Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events after each vaccination
timeFrame: 30 days after vaccination
Secondary outcomes:
measure: Incidence of serious adverse events after vaccination
timeFrame: day 0 to 6 months after last dose
measure: Blood routine in 2 years and above subjects
timeFrame: 3 days after vaccination
measure: Liver function in 2 years and above subjects
timeFrame: 3 days after vaccination
measure: Renal function in 2 years and above subjects
timeFrame: 3 days after vaccination
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Center for Disease Control and Prevention
state: Guangdong
Study officials:
References: