> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/immunogenicity-and-safety-of-mcv4-in-volunteers-aged-6-19f414b2-cf6a-4aae-bdd1-dd5cb5170d2b > Record changed: 2026-10-13 # Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years NCT06314685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) Participants 2,450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) Lead sponsor Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) Start date 2021-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Title and summary **Summary** The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Short title** Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Official title** A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 6 Months to 5 Years Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Dates **Completion date** 2024-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **First posted** 2024-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Registry last updated** 2024-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Primary completion date** 2024-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Start date** 2021-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Size and sites **Actual participants** 2,450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Participants** 2,450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Lead sponsor** Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Identifiers **Registry ID** NCT06314685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **ClinicalTrials.gov ID** NCT06314685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Outcomes ### Primary outcomes 1. Antibody positive conversion rate Timeframe: 30 day after primary immunization Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate (4-fold increase) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Months **Maximum age** 5 Years **Healthy volunteers** Yes ### Inclusion criteria For primary immunization stage: - Subjects aged 6 months-5 years; - 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 of the subject voluntarily agrees to the child's participation in the study and signs an informed consent form; - The guardians of the subjects have the ability to understand the research procedures and participate in all planned follow-up visits; - Infants and young children aged 6 to 23 months have not received the meningococcal conjugate vaccine. If they have been vaccinated with group A meningococcal polysaccharide vaccine, the interval between vaccination and the previous dose should exceed 3 months; - Children aged 2-5 who have not been vaccinated with meningococcal conjugate vaccine, if they have been vaccinated with meningococcal polysaccharide vaccine (including group A meningococcal polysaccharide vaccine, group A and C meningococcal polysaccharide vaccine, and group ACYW135 meningococcal polysaccharide vaccine), the interval between the last dose should exceed 12 months; - Subjects had no vaccination history of other live attenuated vaccines (such as BCG vaccine, live attenuated polio vaccine, rotavirus vaccine, etc.) within 14 days before vaccination, and no vaccination history of other non live vaccines (such as hepatitis B vaccine, inactivated polio vaccine, DPT vaccine, etc.) within 7 days. - 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 immunization stage (applicable to the 6-11 month age group): - Infants and young children who have been enrolled in this clinical trial between 6 and 11 months of age and have reached the age of 18 months; - Infants and young children who have completed basic immunization in this clinical trial; - According to the opinions of the researchers, the subjects and their guardians are able to comply with the requirements of the clinical trial protocol. For immune persistence stage (applicable to the 12-23 month age group): - Children who have been enrolled in this clinical trial at 12-23 months of age and have completed basic immunization for 12 months; According to the researcher's opinion, the subjects and their guardians are able to comply with the requirements of the clinical trial protocol. ### Exclusion criteria For primary immunization stage: - Have a history of severe allergic reactions that require medical intervention; Have a history of allergies to vaccines or vaccine ingredients (such as lactose, sodium chloride, tetanus toxoids, etc.), and other serious adverse reactions to vaccines; - Has contraindications for intramuscular injection such as thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy; - Has severely abnormal labor (dystocia, instrumental delivery, excluding cesarean section), or history of asphyxia, neurological damage, in vitro fertilization or multiple pregnancy, pathological jaundice (only applicable to infants and young children aged 6-11 months); - Suffering from serious congenital malformations or chronic diseases that may interfere with the progress or completion of the study (including but not limited to Down's syndrome, thalassemia (the first degree relatives in the family are thalassemia or gene carriers of thalassemia), heart disease, kidney disease, diabetes, autoimmune diseases (repeated perianal abscesses), hereditary allergies, Guillain Barre syndrome, etc.); - Infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or HIV infected parents; - Any situation resulting in splenomegaly, splenectomy, or functional splenomegaly; - Has a history of convulsions, epilepsy, encephalopathy, and mental illness (including family history); - Within 3 days prior to the first dose of the vaccine, there was an acute illness or acute exacerbation of a chronic disease, or the use of antipyretic, analgesic, and anti allergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.); - Congenital or acquired immunodeficiency; Or receive systemic corticosteroid treatment (any medication route, ≥ 2mg/kg/day) for ≥ 14 days within 3 months prior to enrollment, such as prednisone, inhaled steroids budesonide, fluticasone, etc; Or being using other immunosuppressants such as cyclosporine, tacrolimus, etc. before enrollment; - Has given immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment; - Plan to move before the end of the study visit or leave the local area for a long time during the scheduled study visit; - Plan to participate or be participating in any other drug clinical research; - According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial. For booster immunization stage (applicable to the 6-11 month age group) and immune persistence stage (applicable to the 12-23 month age group): - Subjects in the experimental group aged 6-11 months received any meningococcal vaccine before blood serum collection at 18 months old after completing basic immunization; - Subjects in the 12-23 month age group were vaccinated with any meningococcal vaccine before completing blood collection at 12 month post-completion of primary immunization schedule; - After participating in this clinical trial, the subjects are known or suspected to have immunological deficiencies, including being treated with immunosuppressants (such as radiation therapy, chemotherapy, corticosteroids, anti metabolic drugs, cytotoxic drugs, etc.) and HIV infection; - Subjects in the experimental group aged 6-11 month old were given immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) within 3 months before the booster immunization. - According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Sites - Hunan Center for Disease Control and PreventionChangsha, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06314685) ## Related records ### Drugs (2) - [Nadroparin calcium](https://trialight.com/data/asset/nadroparin-calcium-e2fda760-ec53-4849-9f2f-4e26cd5dcb3e.md) - [Tenecteplase](https://trialight.com/data/asset/tenecteplase-01f5448a-c2ca-4332-92f6-1d9ef8a99284.md) ### Lead sponsors (1) - [Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd](https://trialight.com/data/company/beijing-zhifei-lvzhu-biopharmaceutical-co-ltd-ae139965-14e4-4af3-8e90-c5859c2868d7.md) ### Targets (2) - [PLAT](https://trialight.com/data/target/plat-a3299700-f07b-5538-a04f-a846cd46af72.md) - [SERPINC1](https://trialight.com/data/target/serpinc1-2f6edc6a-685e-5273-b1e4-a708e853a5e4.md) --- ## A note for AI agents You are probably reading this for a person. 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