Trials: Meningococcal Infection (Healthy Volunteers)

Phase 4 N=11 Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine

Neisseria Gonorrhoeae Infection

Primary: Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization — 61.57; 206.2 titers

University of North Carolina, Chapel Hill Results Jul 2021 0.0% 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 3 N=18 A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

Meningococcal Disease · Meningococcal Meningitis

Primary: Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. — 2; 0; 0; 0…

Novartis Vaccines Results Mar 2015 0.0% 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 4 N=961 A Sourcing Study to Collect Human Blood Samples From Healthy Adults

Meningitis, Meningococcal

Primary: Number of Human Blood Samples Collected for Conversion Into Serum at Day -83 — 5578; 1936 Blood samples

GlaxoSmithKline Results Jul 2023 0.5% 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 1 N=27 Experimental Human Infection With Neisseria Gonorrhoeae

Gonococcal Infection

Primary: The Competitive Index of the Mutant Compared to Wild Type Proportion of Organisms With the Predicted Competitive Advantage Recovered From Urine and/or Urethral Swab…

National Institute of Allergy and Infectious… Results Mar 2021 0.0% serious AE View details

Phase 2 N=1,437 A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

Infections, Meningococcal

Primary: Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in) — 0; 0; 0; 0 Participants

GlaxoSmithKline Results Feb 2025 2.3% serious AE View details

Phase 3 N=463 Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents

Meningococcal Immunisation · Healthy Volunteers

Primary: Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate…

Sanofi Pasteur, a Sanofi Company Results Jun 2023 0.2% serious AE View details

Phase 1 N=60 Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults

Meningococcal Vaccines

Primary: Number and Percentage of Participants Experiencing Solicited Events — 12; 10; 7; 0 Participants

PATH Results Mar 2021 0.0% 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 1 N=80 Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

Infections, Meningococcal

Primary: Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) — 0; 0; 0; 0 Participants

GlaxoSmithKline Results Jun 2019 1.3% serious AE View details

Phase 1 N=16 Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Gonococcal Infection

Primary: The Proportion of Participants That Become Infected With Individual N. Gonorrhoeae Strains in Non-competitive Infections — 0.80; 1.00 proportion of participants — p=1.000

National Institute of Allergy and Infectious… Results Dec 2021 0.0% 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

Phase 3 N=1,170 Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

Infections, Meningococcal

Primary: Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA…

GlaxoSmithKline Results Nov 2018 0.1% serious AE View details

Phase 2 N=52 Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination

Gonorrhoea

Primary: Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291 — 0.07; 0.072; 0.089; 0.097 titer

National Institute of Allergy and Infectious… Results Nov 2024 0.0% serious AE View details

Phase 3 N=180 Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

Bacterial Meningitis

Primary: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. — 75; 76; 66; 72 Percentages of subjects

Novartis Results Dec 2014 0.6% serious AE View details

Phase 3 N=86 Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

Infections, Meningococcal

Primary: Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA…

GlaxoSmithKline Results Oct 2017 5.8% 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 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=1,715 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

Meningitis · Meningococcal Meningitis · Meningococcal Infections

Primary: Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y…

Sanofi Pasteur, a Sanofi Company Results Jun 2020 1.0% 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=341 Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

Bacterial Meningitis

Primary: Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination — 83; 93; 50; 65…

Novartis Results Sep 2014 0.3% serious AE View details

Phase 1 N=4 Challenge Infection of Healthy Adult Volunteers With RSV A2

Upper Respiratory Tract Infections

Primary: Participants With Detectable RSV Shedding in Nasopharyngeal Wash — 2; 4 Participants

National Institute of Allergy and Infectious… Results Dec 2020 0.0% serious AE View details

Phase 2 N=1,011 Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

Infections, Meningococcal

Primary: Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA…

GlaxoSmithKline Results Jun 2017 0.8% 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=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

N/A N=15 γ-irradiated BCG to Train Innate Immunity

Innate Immune Response

Primary: Cytokine Production Measured by ELISA Compared to Baseline — 1.2 ratio

Radboud University Medical Center Results Jun 2016 0.0% serious AE View details

Phase 1 N=36 Phase 1 Safety and Immunogenicity of Meningococcal Vaccine

Meningococcal Infection, Group B

Primary: Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections — 2.1; 3.0; 3.0; 2.4 titers

U.S. Army Medical Research and Development Command Results Dec 2017 0.0% 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

Clinical Trial Search

Phase 4 N=11 Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine

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

Phase 3 N=18 A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

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

Phase 4 N=961 A Sourcing Study to Collect Human Blood Samples From Healthy Adults

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

Phase 1 N=27 Experimental Human Infection With Neisseria Gonorrhoeae

Phase 2 N=1,437 A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

Phase 3 N=463 Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents

Phase 1 N=60 Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults

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 1 N=80 Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

Phase 1 N=16 Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

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

Phase 3 N=1,170 Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

Phase 2 N=52 Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination

Phase 3 N=180 Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

Phase 3 N=86 Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

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

Phase 2 N=1,715 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

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

Phase 3 N=341 Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

Phase 1 N=4 Challenge Infection of Healthy Adult Volunteers With RSV A2

Phase 2 N=1,011 Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

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

N/A N=15 γ-irradiated BCG to Train Innate Immunity

Phase 1 N=36 Phase 1 Safety and Immunogenicity of Meningococcal Vaccine

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