Trials: Meningococcal Immunisation (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 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=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 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 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 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 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 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 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=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 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=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=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 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=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 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 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 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 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=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 3 N=369 Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

Infections, Meningococcal

Primary: Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY) — 134; 55; 151; 56 Participants

GlaxoSmithKline Results Apr 2017 0.3% 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 3 N=198 Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

Meningococcal Disease

Primary: Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination — 85; 74; 60; 83 Percentage of subjects

Novartis Vaccines Results Mar 2014 0.0% serious AE View details

Phase 1 N=31 A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1

Malaria

Primary: Safety and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events…

University of Oxford Results Nov 2019 6.5% 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=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 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=1,328 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

Meningococcal Immunization · Healthy Volunteers

Primary: Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W — 89.6; 83.1; 99.3; 77.7…

Sanofi Pasteur, a Sanofi Company Results Feb 2025 0.2% serious AE View details

Phase 3 N=1,409 A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

Meningococcal Disease · Meningococcal Meningitis

Primary: Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of…

Novartis Vaccines Results Jan 2016 4.1% 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

Clinical Trial Search

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

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

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

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

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

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

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

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

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

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

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

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

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

Phase 3 N=369 Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

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

Phase 3 N=198 Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

Phase 1 N=31 A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1

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

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

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

Phase 3 N=1,328 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

Phase 3 N=1,409 A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

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