Trials: Meningitis

Phase 2 N=378 Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth

HIV Infections · Meningitis

Primary: Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses…

National Institute of Allergy and Infectious… Results May 2014 4.2% serious AE View details

Phase 4 N=375 Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis

Bacterial Meningitis

Primary: Day 7 Mortality — 61; 64 Participants

University of Helsinki Results Sep 2019 0.0% serious AE View details

Phase 1 N=34 Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.

Meningitis, Meningococcal, Serogroup B

Primary: Safety: Severity Summary of Solicited and Unsolicited Adverse Events — 67; 92; 70; 3 AEs

U.S. Army Medical Research and Development Command Results Oct 2018 0.0% serious AE View details

Phase 2 N=484 Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

Invasive Meningococcal Disease

Primary: Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. — 90…

Novartis Vaccines Results Sep 2014 1.7% serious AE View details

Phase 2 N=601 Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

Prevention of Meningococcal Disease

Primary: Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine — 6; 0; 93; 81 percentages of…

Novartis Vaccines Results Jun 2014 12.2% serious AE View details

Phase 2 N=500 Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine

Infections, Meningococcal

Primary: Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) — 82.7; 69.7; 94.4; 90.3 Percentage of subjects

GlaxoSmithKline Results Jun 2018 0.2% serious AE View details

Phase 2 N=1,713 A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

Meningococcal Vaccine

Primary: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and…

Pfizer Results Jun 2015 2.5% serious AE View details

Phase 3 N=300 A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India

Meningococcal Infection · Meningitis

Primary: Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination — 17; 27; 23; 95 Participants

Sanofi Results Feb 2012 0.0% serious AE View details

N/A N=6,802 Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers

Neisseria Meningitidis

Primary: Estimate the Difference in Carriage Prevalence of Disease Associated Genogroups of N. Meningitidis (A, B, C, W, X, Y) Between School Leavers in 2018 (Year 12 in 2017)…

University of Adelaide Results Nov 2021 0.0% serious AE View details

Phase 3 N=290 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

Healthy Volunteers (Meningococcal Infection)

Primary: Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal…

Sanofi Pasteur, a Sanofi Company Results Mar 2025 2.1% serious AE View details

Phase 2 N=54 Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

Meningococcal Disease

Primary: Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination. — 2.5; 2.3; 1.8; 33 titer

Novartis Vaccines Results Jul 2011 0.0% serious AE View details

Phase 3 N=300 Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

Meningitis · Meningococcal Infection

Primary: Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y…

Sanofi Pasteur, a Sanofi Company Results Aug 2017 1.3% serious AE View details

Phase 2 N=188 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers

Meningitis · Meningococcal Meningitis · Meningococcal Infections

Primary: Number of Participants Reporting Solicited Injection-Site and Systemic Reaction Following Vaccination With Either MenACYW Conjugate Vaccine or NIMENRIX® — 28; 31; 0; 1…

Sanofi Pasteur, a Sanofi Company Results Jun 2020 0.5% serious AE View details

Phase 3 N=3,293 A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

Healthy

Primary: Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite…

Pfizer Results Feb 2016 1.3% serious AE View details

Phase 3 N=2,095 Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

Infections, Meningococcal · Meningococcal Vaccines

Primary: Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y)…

GlaxoSmithKline Results Feb 2019 9.9% serious AE View details

Phase 3 N=2,831 A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

Meningococcal Meningitis · Meningococcal Infections

Primary: Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years — 95; 46 Subjects

Novartis Vaccines Results Aug 2010 0.8% serious AE View details

Phase 2 N=400 A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

MENINGOCOCCAL INFECTION

Primary: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria…

Pfizer Results Mar 2018 1.5% serious AE View details

Phase 2 N=301 Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

Meningitis · Meningococcal Meningitis · Meningococcal Infections

Primary: Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C…

Sanofi Pasteur, a Sanofi Company Results Jun 2020 0.0% serious AE View details

Phase 3 N=1,183 Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers

Meningitis, Meningococcal

Primary: Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With…

Sanofi Pasteur, a Sanofi Company Results Jun 2020 1.2% serious AE View details

Phase 3 N=918 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers

Meningitis · Meningococcal Meningitis · Meningococcal Infections

Primary: Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were…

Sanofi Pasteur, a Sanofi Company Results Jun 2020 0.8% serious AE View details

Phase 2 N=524 Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

Prevention of Meningococcal Disease

Primary: Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without…

Novartis Vaccines Results Nov 2013 2.5% serious AE View details

Phase 2 N=376 Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

Meningitis, Meningococcal

Primary: Severe Solicited Adverse Event — 0; 0; 0; 0 participants

Serum Institute of India Pvt. Ltd. Results Sep 2021 0.4% serious AE View details

Phase 3 N=13 A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.

Prevention of the Meningococcal Disease

Primary: Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule — 1.18; 53; 2.27; 143 Titers

Novartis Vaccines Results Oct 2014 0.0% serious AE View details

Phase 3 N=950 Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Healthy Volunteers (Meningococcal Infection)

Primary: Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second…

Sanofi Pasteur, a Sanofi Company Results Jun 2024 2.5% serious AE View details

Phase 2 N=1,010 Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

Prevention of Meningococcal Disease

Primary: Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine — 6; 1; 228…

Novartis Vaccines Results Feb 2016 1.4% serious AE View details

Phase 2 N=168 High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals

Cryptococcal Meningitis · HIV Infections

Primary: Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B — 14; 11; 11; 6 Participants — p=0.0012

National Institute of Allergy and Infectious… Results Mar 2018 47.0% serious AE View details

Phase 3 N=1,118 A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

Meningococcal Meningitis · Measles · Mumps

Primary: Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) — 96; 93…

Sanofi Pasteur, a Sanofi Company Results Jun 2011 3.8% serious AE View details

Phase 3 N=450 Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia

Neisseria Meningitidis · Meningococcal Infections

Primary: Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination…

Sanofi Pasteur, a Sanofi Company Results Mar 2011 0.2% serious AE View details

Phase 3 N=2,797 Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Healthy Volunteers (Meningococcal Infection)

Primary: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) — 7; 2 Participants

Sanofi Pasteur, a Sanofi Company Results Oct 2023 4.7% serious AE View details

Phase 3 N=239 Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

Meningococcal Disease

Primary: Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain…

Novartis Results Feb 2017 2.9% serious AE View details

Clinical Trial Search

Phase 2 N=378 Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth

Phase 4 N=375 Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis

Phase 1 N=34 Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.

Phase 2 N=484 Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

Phase 2 N=601 Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

Phase 2 N=500 Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine

Phase 2 N=1,713 A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

Phase 3 N=300 A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India

N/A N=6,802 Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers

Phase 3 N=290 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

Phase 2 N=54 Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

Phase 3 N=300 Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

Phase 2 N=188 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers

Phase 3 N=3,293 A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

Phase 3 N=2,095 Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

Phase 3 N=2,831 A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

Phase 2 N=400 A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

Phase 2 N=301 Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

Phase 3 N=1,183 Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers

Phase 3 N=918 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers

Phase 2 N=524 Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

Phase 2 N=376 Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

Phase 3 N=13 A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.

Phase 3 N=950 Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Phase 2 N=1,010 Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

Phase 2 N=168 High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals

Phase 3 N=1,118 A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

Phase 3 N=450 Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia

Phase 3 N=2,797 Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Phase 3 N=239 Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.