Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.

NCT04236960 | Completed Phase 1

• 1 other identifier: 008152017002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningococcal Infections

Keywords

Meningitis, Meningococcal, Serogroup A; Meningitis, Meningococcal, Serogroup C; Meningitis, Meningococcal, Serogroup Y; Meningitis, Meningococcal, Serogroup W135

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events after each vaccination

  Percentage of subjects with local and systemic adverse events after each dose of vaccination

  30 days after vaccination

Secondary Outcomes (4)

• Incidence of serious adverse events after vaccination

  day 0 to 6 months after last dose

• Blood routine in 2 years and above subjects

  3 days after vaccination

• Liver function in 2 years and above subjects

  3 days after vaccination

• Renal function in 2 years and above subjects

  3 days after vaccination

Study Arms (5)

18~55 yrs

EXPERIMENTAL

1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.

Biological: Meningococcal Group ACYW135 Conjugate Vaccine

2~17 yrs

EXPERIMENTAL

1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.

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.

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.

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.

Biological: Meningococcal Group ACYW135 Conjugate Vaccine

Interventions

Meningococcal Group ACYW135 Conjugate Vaccine BIOLOGICAL

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)

18~55 yrs; 2 mos; 2~17 yrs; 3 mos; 7~23 mos

Eligibility Criteria

• Age: 2 Months - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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℃.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Walvax Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial Center for Disease Control and Prevention

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: January 22, 2020
• Study Start: July 17, 2018
• Primary Completion: September 16, 2019
• Study Completion: November 28, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CN (1)