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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236960
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Walvax Biotechnology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Meningococcal Infections Biological: Meningococcal Group ACYW135 Conjugate Vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Clinical Study of Meningococcal Group ACYW135 Conjugate Vaccine
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : September 16, 2019
Actual Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18~55 yrs
1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.
Biological: Meningococcal 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)

Experimental: 2~17 yrs
1 dose of meningococcal group ACYW135 conjugate vaccine will be administered on day 0.
Biological: Meningococcal 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)

Experimental: 7~23 mos
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
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.
Biological: Meningococcal 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)

Experimental: 2 mos
3 doses of meningococcal group ACYW135 conjugate vaccine will be administered. Two-month interval between every two doses.
Biological: Meningococcal 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)




Primary Outcome Measures :
  1. Incidence of adverse events after each vaccination [ Time Frame: 30 days after vaccination ]
    Percentage of subjects with local and systemic adverse events after each dose of vaccination


Secondary Outcome Measures :
  1. Incidence of serious adverse events after vaccination [ Time Frame: day 0 to 6 months after last dose ]
    Percentage of subjects with serious adverse events from day 0 to 6 months after last dose

  2. Blood routine in 2 years and above subjects [ Time Frame: 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

  3. Liver function in 2 years and above subjects [ Time Frame: 3 days after vaccination ]
    Alanine aminotransferase(ALT),Aspartate aminotransferase(AST),Total bilirubin(TBIL) 3 days after vaccination in 2 years and above subjects

  4. Renal function in 2 years and above subjects [ Time Frame: 3 days after vaccination ]
    Creatinine(CR),Urea nitrogen(BUN)3 days after vaccination in 2 years and above subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236960


Locations
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China, Guangdong
Guangdong Provincial Center for Disease Control and Prevention
Guangzhou, Guangdong, China
Sponsors and Collaborators
Walvax Biotechnology Co., Ltd.

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Responsible Party: Walvax Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04236960    
Other Study ID Numbers: 008152017002
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walvax Biotechnology Co., Ltd.:
Meningitis, Meningococcal, Serogroup A
Meningitis, Meningococcal, Serogroup C
Meningitis, Meningococcal, Serogroup Y
Meningitis, Meningococcal, Serogroup W135
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs