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Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 5 Months

NCT05252715•Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

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 to 5 months.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For primary vaccination
•Subjects aged 3-5 months;
•Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
•Axillary body temperature ≤ 37.0 ℃;
•The guardian signs the informed consent form;
•The guardian and his family agree to comply with the requirements of the clinical trial protocol;
•Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine at the aged of 3-5 months;
•Subjects who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
•For booster vaccination
•Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
+1 more criteria

Exclusion Criteria

•For primary vaccination
•Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
•History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
•A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
•History of Abnormal production process, asphyxia rescue, or congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
•Have been diagnosed as infectious diseases, such as tuberculosis, viral hepatitis or their parents infected with human immunodeficiency virus (HIV);
•Have progressive nervous system diseases such as encephalopathy, epilepsy, convulsions or related family history;
•History of acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) or take antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) in the past 3 days;
•History of using illegal drugs (receiving systemic corticosteroid treatment≥2mg/kg/day through any route of administration, and using ≥14 days, such as prednisone, inhaled hormone budesonide, fluticasone, etc., or receiving other immunosuppressants, such as cyclophosphamide, etc.);
•History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
+7 more criteria

Locations (2)

Liujiang Center for Disease Control and Prevention

Liuchow, Guangxi, China

Binyang Center for Disease Control and Prevention

Nanning, Guangxi, China

Key Dates

Start Date

December 18, 2021

Primary Completion Date

August 22, 2023

Completion Date

September 18, 2024

Last Updated

April 4, 2024

Enrollment

1,200

ESTIMATED participants

Conditions

Meningitis, Meningococcal

Interventions

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

BIOLOGICAL

Meningococcal A and C Polysaccharide Conjugate Vaccine

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

Inclusion Criteria

Exclusion Criteria

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants