Clinical Trials for Meningococcal Disease

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Meningococcal Disease from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 8
• Active, not recruiting: 14
• Completed: 20
• Other: 8

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04664569 — National Bacterial Meningitis Study in Children and Newborns

Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated…

NCT04843111 — Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)

Primary Objective:

To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).

NCT06025487 — Meningococcal B Vaccine in Patients with Asplenia

Patients without a spleen (asplenia) experience an increased risk for septicaemia from encapsulated bacteria, which is associated with a high mortality rate. Meningococcal bacteria can cause such infections and serogroup B is the dominant meningococcal subtype in Europe. Therefore, vaccination for risk populations like patients without a spleen is a pressing matter. Considering the effectivenes…

NCT06832514 — Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons

Sexual differences are a well-established source of biological variation in immune system functioning, with men often displaying lower adaptive immune responses (e.g. antibody production) to infections and vaccinations compared to women. The impact of sex and gender on immune responses and immune functioning warrants more in-depth investigation. This study is an investigator-initiated project a…

NCT07204457 — Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old

Phase 2/3 study to evaluate immunogenicity and safety in healthy adult participants following a single dose administration of Meningococcal (groups A, C, W-135, and Y) conjugate vaccine

NCT07203755 — Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine/placebo groups.

NCT07252804 — Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases

The goal of this clinical trial is to evaluate the humoral immunogenicity of the meningococcal B vaccine (MenB-4C) in pediatric patients with autoimmune rheumatic diseases (ARDs), compared to age- and sex-matched non-immunosuppressed controls.

The main questions it aims to answer are:

• To assess the influence of treatment on the response to the MenB-4C vaccine in patients with ARDs;
• To eva…

NCT07379151 — Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine

This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.

Active, Not Recruiting

NCT04350138 — Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection

This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 primary endpoints in the Per Protocol Popul…

NCT04415424 — Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men

This is a Phase 3, double-blinded, randomised placebo-controlled, multi-centred trial evaluating the efficacy of the four-component meningococcal B vaccine, 4CMenB (Bexsero®), in the prevention of Neisseria gonorrhoeae infection.The targeted population is 18-50 years-old men (cis and trans), trans women and non-binary people who have sex with men (hereafter referred to as Gay Bisexual Men+ [GB…

NCT05087056 — Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

NCT05766904 — Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Objectives: Efficacy of a meningococcal vaccine against Neisseria gonorrhoea (NG) infection among men who have sex with men (MSM).

Design: Parallel randomised double-blind placebo-controlled trial.

Setting: A teaching hospital in Hong Kong.

Participants: 150 adult MSM at risk of gonorrhoea infection (condomless sex with more than one man within the last six months, history of sexually transm…

NCT05935176 — Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 …

NCT06113198 — A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age

The purpose of this study is to assess the safety and immune responses of rMenB+OMV NZ vaccine when administered to healthy infants from 2 months in the Republic of Korea according to a 2-dose primary schedule and 1 booster dose.

NCT06226714 — A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.

NCT06131554 — A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group ran…

NCT06389513 — Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants

This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is …

NCT06446752 — BIYELA - Bexsero Immunisation in Young Women in Africa

This proposed 2-arm randomized evaluation of two doses of 4CMenB vaccine versus placebo at Enrollment and Month 2 is designed as a proof-of-concept study to inform potential use for dual meningococcal B and gonococcal prevention, and to inform Neisseria gonorrheae vaccine development.

NCT06647407 — Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

This study is the first study of Sanofi’s Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in todd…

NCT06700148 — A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

This is a randomized, blinded, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups, afterwards some subjects entered the immune p…

NCT06906692 — Meningococcal Vaccination in Patients on Complement Inhibitors

Myasthenia gravis is an autoimmune neurological disorder caused by autoantibodies directed predominantly against components of the postsynaptic membrane of the neuromuscular junction. Anti-aquaporin-4 antibody-associated neuromyelitis optica (AQP4-IgG) is an autoimmune inflammatory disease of the central nervous system (CNS) characterized by three main clinical manifestations: transverse myelit…

NCT07135986 — Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.

Study details include:

• The study duration will be approximately 180 days.
• The vaccination visit will be…

Not Yet Recruiting

NCT07374510 — Phase Ia Clinical Trial of Group ACYW135X Meningococcal Conjugate Vaccine

This trial adopts an open-label design combined with randomized, blinded, placebo-controlled and active-controlled design. The purpose of this trial is to evaluate the safety and immunogenicity of a Group ACYW135X Meningococcal Conjugate Vaccine. This study is planned to enroll 150 participants in total, with healthy individuals aged 2 to 59 years as participants. Among them, participants aged …

NCT07505836 — Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months

The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months.

The main questions it aims to answer are:

Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vacci…

NCT07505888 — Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years

The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 meningococcal conjugate vaccine in healthy children aged 2 to 6 years.

The main questions it aims to answer are:

Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine, as measured by serum antibody levels? What safety pro…

NCT07505810 — Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months

The goal of this clinical trial is to evaluate the immunogenicity, safety, and immune persistence of the primary series of an investigational group ACYW135 meningococcal conjugate vaccine, as well as the immunogenicity and safety of a booster dose administered at 12 months of age, in healthy children aged 3 to 5 months.

The main questions it aims to answer are:

Is the immune response induced …

NCT07505823 — Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 6-11 Months

The goal of this clinical trial is to evaluate the immunogenicity, safety, and persistence of the immune response of a group ACYW135 meningococcal conjugate vaccine in healthy children aged 6 to 11 months.

The main questions it aims to answer are:

Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine following the primary series? Wh…

NCT07671014 — Metagenomic Analysis of the Pharynx in High Risk Partners

The Neisseria gonorrhoea (NG) epidemic in England is at the highest level in one hundred years of public health records. The World Health Organisation has listed NG as one of the top five bacterial infections globally because of the ability of the bacteria to develop resistance to antibiotics. Neisseria meningitidis (NM) is a common pharyngeal commensal and it has been shown to be in one in fiv…

Completed Trials

NCT01593514 — Understanding the Immune Response to Two Different Meningitis Vaccines

The bacterium (germ) Neisseria meningitidis causes meningitis and blood poisoning. N meningitidis is classified into different serogroups (types), based on its outer polysaccharide (carbohydrate) capsule. Serogroups A,B,C,W & Y are responsible for the vast majority of meningococcal disease worldwide.

Older vaccines against types A,C,W & Y contain part of the polysaccharide capsule of the ger…

NCT03295318 — Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet.

Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine aga…

NCT03537508 — Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

NCT03621670 — Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

NCT03547271 — Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Primary objective:

This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and d…

NCT03869866 — Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon

The primary objectives of this study are:

• To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine
• To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hS…

NCT04142242 — Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49

Primary Objective:

To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary vaccination with Menomune vaccine greater than or equal to [>= 3] years earlier a…

NCT04061382 — Sero-epidemiological Survey of England in 2019/2020 - COVID-19

This is a pilot study to assess the feasibility of establishing a national sero-epidemiological survey in England in individuals aged 0-24 years, focusing on assessing humoral immunity against diphtheria, Group C invasive meningococcus and SARS-CoV-2. The investigators will recruit 2800 to 3800 individuals, divided into three groups:

Group one (N= 2300):

This will include all age groups (0-24…

NCT04318548 — Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

NCT04665791 — A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults

This study is part of a series of projects to improve protection against meningitis. Previously, researchers have given nose drops containing N. lactamica to over 400 volunteers and shown that many of them become colonised with N. lactamica without causing any illness or disease. This has previously been shown to prevent people from becoming colonised with N. meningitidis which can cause mening…

NCT04886154 — A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of th…

NCT04893811 — Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.

NCT04722003 — Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination

This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae, using a placebo vaccine (normal saline) as a comparator (group 2, 10 subjects). There will be approximately 50 participants, ages 18-49, both male and non-pregnant fema…

NCT05082285 — A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

NCT05093829 — Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine

Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to t…

NCT05873751 — A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.

Brief Summary:

The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection.

This study looks at data records from a database in the United States.

This study includes patient’s data from the database who:

• Are 15-30 years old.
• Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.

…

NCT06011200 — A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population

The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can often cause serious disease epidemics…

NCT06228586 — Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam

The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam.

The primary objectives of the study were:

• To describe t…

NCT06618534 — Azithromycin for Meningococcal Carriage

The purpose of this study is to determine the effectiveness of azithromycin in the eradication of nasopharyngeal carriage of N. meningitidis

NCT06995430 — A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old)

The main purpose of this study is to evaluate the immune response and safety of a booster dose of the meningococcal group B vaccine, rMenB+OMV NZ (also known as Bexsero), in adolescents and young adults aged 10 to 20 years. This study focuses on individuals who were first vaccinated with rMenB+OMV NZ as infants. The primary hypothesis is that a booster dose of the vaccine will elicit a stronger…

Other (Terminated)

NCT03549325 — A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

This study is part of a project that aims to develop a vaccine with N. lactamica that prevents meningitis. The investigators have previously given nose drops containing N. lactamica to over 340 volunteers, and shown that many of the volunteers (35-60%) become colonised without causing any illness or disease. In the future the investigators would like to modify N. lactamica so that it can carry …

NCT04685850 — Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans

While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.

The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents wi…