Trials: Meningococcal Immunisation

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 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=810 Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Meningitis · Meningococcal Meningitis · Meningococcal Infections

Primary: Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine…

Sanofi Pasteur, a Sanofi Company Results Jun 2020 1.1% 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

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=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=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 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=123 Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

Meningitis · Meningococcal Infection

Primary: Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age…

Sanofi Pasteur, a Sanofi Company Results May 2013 2.4% 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=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=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=1,325 Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine

Meningitis

Primary: Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y — 373; 191; 366; 180 Participants

Emory University Results May 2024 0.4% serious AE View details

Phase 3 N=264 Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

Meningococcal Disease

Primary: Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. — 26; 24; 98; 27 percentage of…

Novartis Vaccines Results Mar 2015 0.8% 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

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=1,885 Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

Meningococcal Infections

Primary: Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine — 9; 7; 6; 6 Percentages of subjects

Novartis Vaccines Results Mar 2015 8.4% 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 4 N=389 Immunogenicity of the Booster Dose of Two MenC Vaccines

Meningococcal Infection

Primary: Serum Bactericidal Activity Against MenC — 6786; 6278; 2061; 1746 GMTs

Centro Superior de Investigación en Salud Publica Results Oct 2013 3.1% 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 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 3 N=1,620 A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

Meningococcal Meningitis · Human Papillomavirus Infection · Pertussis

Primary: Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse — 80; 82; 87; 83 Percentage of participants

Novartis Vaccines Results Oct 2010 0.7% serious AE View details

Phase 3 N=91 Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children

Meningococcal Infections

Primary: Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW…

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

Phase 3 N=906 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

Meningitis · Meningococcal Meningitis · Meningococcal Infections

Primary: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune®…

Sanofi Pasteur, a Sanofi Company Results Feb 2020 3.3% 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 3 N=788 Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom

Healthy Volunteers (Meningococcal Infection)

Primary: Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Vaccination…

Sanofi Pasteur, a Sanofi Company Results Nov 2023 7.5% serious AE View details

Phase 3 N=1,072 Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Meningococcal Disease · Meningococcal Meningitis

Primary: Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given…

Novartis Vaccines Results Jun 2014 0.3% 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 3 N=1,500 Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

Meningococcal Disease

Primary: Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS — 93; 55; 82; 52 Percentage of…

Novartis Vaccines Results Nov 2013 0.7% serious AE View details

Clinical Trial Search

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

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

Phase 3 N=810 Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

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

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

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

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

Phase 3 N=123 Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

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

Phase 3 N=1,325 Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine

Phase 3 N=264 Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

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

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

Phase 2 N=1,885 Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

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

Phase 4 N=389 Immunogenicity of the Booster Dose of Two MenC Vaccines

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

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

Phase 3 N=1,620 A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

Phase 3 N=91 Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children

Phase 3 N=906 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

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

Phase 3 N=788 Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom

Phase 3 N=1,072 Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

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

Phase 3 N=1,500 Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age