A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine

NCT04689191 | Unknown Phase 3

• 1 other identifier: 20190702
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A and C meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 2-6 years.

Conditions

Meningitis, Meningococcal

Outcome Measures

Primary Outcomes (2)

• Seroconversion rate of Group A meningococcal bactericidal antibody

  Seroconversion rate of Group A meningococcal bactericidal antibody at day 28 after vaccination

  28 days after vaccination

• Seroconversion rate of Group C meningococcal bactericidal antibody

  Seroconversion rate of Group C meningococcal bactericidal antibody at day 28 after vaccination

  28 days after vaccination

Secondary Outcomes (5)

• Adverse reactions/events rate

  7 days after vaccination

• Adverse reactions/events rate

  28 days after vaccination

• Serious adverse events

  6 months after the second vaccination

• GMT of Group A meningococcal bactericidal antibody

  28 days after the second vaccination

• GMT of Group C meningococcal bactericidal antibody

  28 days after the second vaccination

Other Outcomes (2)

• GMT of IgG antibody against Hepatitis A

  28 days after the second vaccination

• Seropositive rate of IgG antibody against Hepatitis A

  28 days after the second vaccination

Study Arms (2)

Experimental Vaccine

EXPERIMENTAL

One dose of Experimental Group A and C meningococcal polysaccharide vaccine

Biological: Experimental Group A and C meningococcal polysaccharide vaccine

Active Comparator Vaccine

ACTIVE COMPARATOR

One dose of Control Group A and C meningococcal polysaccharide vaccine

Biological: Control Group A and C meningococcal polysaccharide vaccine

Interventions

Experimental Group A and C meningococcal polysaccharide vaccine BIOLOGICAL

One dose of Experimental Group A and C meningococcal polysaccharide vaccine

Experimental Vaccine

Control Group A and C meningococcal polysaccharide vaccine BIOLOGICAL

One dose of Control Group A and C meningococcal polysaccharide vaccine

Active Comparator Vaccine

Eligibility Criteria

• Age: 2 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 50 years.
• Proven legal identity.
• Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
• Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
• Axillary temperature ≤37.0℃.

You may not qualify if:

• Contraindications for vaccination.
• History of allergy to vaccines or drugs.
• History of Epidemic Cerebrospinal Meningitis.
• Immunization with any Group A meningococcal conjugate vaccine or polysaccharide vaccine within 12 months.
• Immunization with any Group A and C meningococcal conjugate vaccine or polysaccharide vaccine within 3 years.
• Immunization with any vaccine within 30 days.
• Patients with convulsion, epilepsy, encephalopathy and psychiatric history or family history of epilepsy.
• History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
• Those who developed acute disease or acute attack of chronic disease.
• Surgical removal of spleen or other important organs for any reason.
• History of thrombocytopenia or other coagulation disorders may cause contraindication of subcutaneous injection.
• Blood products such as immunoglobulin were received within 30 days before vaccination.
• Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months before signing the informed consent form (Note: inhaled or topical hormone drugs, except those with an interval of 14 days or more from the date of signing the informed consent form).
• Those who participated in other clinical studies.
• Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 12 months after the second vaccination.

Sponsors & Collaborators

• Wei Cun: lead
• Yunnan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Yunnan Center for Disease Control and Prevention

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

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

Study Officials

• Yan Zheng, Mater

  Yunnan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Cun, Doctor

CONTACT

+86-13629464497; cunwei@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 30, 2020
• Study Start: September 15, 2020
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)