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
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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…
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
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
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
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…
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…
Phase 2 N=103 Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
Meningitis · Meningococcemia
Primary: Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination. — 136.33; 99.66; 11404.16; 199.31…
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…
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…
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…
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
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…
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
Phase 2 N=216 B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
Meningococcal Disease
Primary: Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y — 2.10; 1.80; 1.72; 2.57 B cells per 2x100000 lymphocytes — p=0.69
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…
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…
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…
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…
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
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…
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…
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…
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…
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…
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
Phase 3 N=360 Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
Meningococcal Immunisation (Healthy Volunteers)
Primary: Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine…
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
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®…
Phase 3 N=2,627 Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
Healthy Volunteers (Meningococcal Infection)
Primary: Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month…