search
Back to results

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

Primary Purpose

Meningococcal Infections

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Meningococcal Group ACYW135 Conjugate Vaccine
Sponsored by
Walvax Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Infections focused on measuring Meningitis, Meningococcal, Serogroup A, Meningitis, Meningococcal, Serogroup C, Meningitis, Meningococcal, Serogroup Y, Meningitis, Meningococcal, Serogroup W135

Eligibility Criteria

2 Months - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Guangdong Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

18~55 yrs

2~17 yrs

7~23 mos

3 mos

2 mos

Arm Description

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

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

2 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between the first and second dose.

3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between every two doses.

3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. Two-month interval between every two doses.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of serious adverse events after vaccination
Percentage of subjects with serious adverse events from 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
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
Renal function in 2 years and above subjects
Creatinine(CR),Urea nitrogen(BUN)3 days after vaccination in 2 years and above subjects

Full Information

First Posted
July 5, 2018
Last Updated
January 16, 2020
Sponsor
Walvax Biotechnology Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04236960
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
November 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walvax Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infections
Keywords
Meningitis, Meningococcal, Serogroup A, Meningitis, Meningococcal, Serogroup C, Meningitis, Meningococcal, Serogroup Y, Meningitis, Meningococcal, Serogroup W135

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18~55 yrs
Arm Type
Experimental
Arm Description
1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.
Arm Title
2~17 yrs
Arm Type
Experimental
Arm Description
1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.
Arm Title
7~23 mos
Arm Type
Experimental
Arm Description
2 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between the first and second dose.
Arm Title
3 mos
Arm Type
Experimental
Arm Description
3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. One-month interval between every two doses.
Arm Title
2 mos
Arm Type
Experimental
Arm Description
3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. Two-month interval between every two doses.
Intervention Type
Biological
Intervention Name(s)
Meningococcal Group ACYW135 Conjugate Vaccine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Incidence of adverse events after each vaccination
Description
Percentage of subjects with local and systemic adverse events after each dose of vaccination
Time Frame
30 days after vaccination
Secondary Outcome Measure Information:
Title
Incidence of serious adverse events after vaccination
Description
Percentage of subjects with serious adverse events from day 0 to 6 months after last dose
Time Frame
day 0 to 6 months after last dose
Title
Blood routine in 2 years and above subjects
Description
content of hemoglobin(g/dL)、white blood cell count(WBC)、blood platelet count(PLT)3 days after vaccination in 2 years and above subjects
Time Frame
3 days after vaccination
Title
Liver function in 2 years and above subjects
Description
Alanine aminotransferase(ALT),Aspartate aminotransferase(AST),Total bilirubin(TBIL) 3 days after vaccination in 2 years and above subjects
Time Frame
3 days after vaccination
Title
Renal function in 2 years and above subjects
Description
Creatinine(CR),Urea nitrogen(BUN)3 days after vaccination in 2 years and above subjects
Time Frame
3 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Guangdong Provincial Center for Disease Control and Prevention
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs