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Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 35 Months

Sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05229536
Collaborator
(none)
720
Enrollment
1
Location
2
Arms
11
Actual Duration (Months)
65.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 35 years.

Condition or Disease Intervention/Treatment Phase
  • Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
  • Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
720 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Single-center, Randomized, Double-blind, Parallel Control Phase II Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 35 Months
Actual Study Start Date :
Dec 21, 2018
Actual Primary Completion Date :
Nov 21, 2019
Actual Study Completion Date :
Nov 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: High dose Group

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 40μg/dose

Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Group 1: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.
Experimental: Low dose Group

Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20μg/dose

Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Group 2: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.

Outcome Measures

Primary Outcome Measures

  1. Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate [30 day after each vaccination]

  2. Safety study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by the occurrence of adverse events [30 day after each vaccination]

    Evaluate the incidence of adverse reactions for Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 35 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • People aged 3-35 months;

  • Subject who has not been vaccinated with meningococcal group A and C conjugate vaccine, meningococcal group A polysaccharide vaccine and meningococcal group A and C and haemophilus b conjugate vaccine at the aged of 3-11 months, and who have't given boost immunity above 1 year old, and they all meet the physical examination requirements of the project;

  • Infants aged 3-11 months should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);

  • The guardian signs the informed consent form;

  • The guardian and his family agree to comply with the requirements of the clinical trial protocol;

  • Subject who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;

  • Axillary body temperature ≤ 37.0 ℃.

Exclusion Criteria:

  • History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);

  • Have a history of allergy to the vaccine or vaccine ingredients (especially those allergic to tetanus toxoid), or have a history of other serious adverse reactions to the vaccine;

  • A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;

  • Abnormal production process, asphyxia rescue history, or congenital malformation, developmental disorder or serious chronic disease;

  • Has serious cardiovascular, liver and kidney diseases or congenital abnormalities and HIV infection;

  • Suffer from encephalopathy, uncontrolled epilepsy, convulsion and other progressive nervous system diseases;

  • Acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) in the past 3 days;

  • Plan to participate or be participating in any other drug clinical research;

  • The interval between the first dose of test vaccine and meningococcal group A polysaccharide vaccine is less than 28 days;

  • According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rongan Center for Disease Control and Prevention Liuzhou Guangxi China 530028

Sponsors and Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Investigators

  • Study Chair: Lin Du, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT05229536
Other Study ID Numbers:
  • 201719805
First Posted:
Feb 8, 2022
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Meningitis, Meningococcal
Meningitis
Vaccines

Study Results

No Results Posted as of Feb 25, 2022