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
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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 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=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 1 N=240 Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
Infection by Streptococcus Group B
Primary: Part A Number of Participants With Treatment Emergent Adverse Events — 6; 5; 5; 6 participants
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
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=667 Prevention of GBS Colonization Via Immunity
Beta Haemolytic Streptococcal Infection
Primary: The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture…
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 3 N=1,184 Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Infections, Meningococcal
Primary: Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1 — 156; 100; 39; 25 Participants
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=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 2 N=396 Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Meningococcal B Disease
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 3 N=750 Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
Infections, Meningococcal
Primary: Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains — 92; 104; 1850; 1790 Titers
Phase 2 N=75 Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
GBS Disease · Streptococcus Agalactiae
Primary: Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age — 6.98; 0.24; 6.18; 0.39 µg/mL
Phase 3 N=3,638 Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
Infections, Meningococcal
Primary: Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 3-dose (0,2,6-M)…
Phase 3 N=55 Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
Meningitis, Meningococcal, Serogroup B
Primary: Number of Subjects Reporting Unsolicited Adverse Events (AEs). — 0; 0; 0; 0 Subjects
Phase 3 N=225 Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
Meningococcal Disease · Infections, Meningococcal
Primary: Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains — 0; 0; 100; 0 Percentages of subjects
Phase 1 N=678 Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Group B Streptococcus
Primary: Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 — 38; 30; 30; 29 percentage of subjects
Phase 2 N=365 A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
Group B Streptococcal Infections
Primary: Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade — 0; 6.3; 12.5; 0…
Phase 1 N=60 Group B Streptococcus Vaccine in Healthy Females
Group B Strep Infection
Primary: Number of Participants With Treatment Emergent Adverse Events — 17; 15; 8 Participants
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…
Phase 2 N=172 Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
Streptococcal Infection · Gram-positive Bacterial Infection · Bacterial Infection
Primary: Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth — 5.39; 0.41; 4.37; 0.4 µg/mL
Phase 3 N=570 Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
Meningococcal Immunisation (Healthy Volunteers)
Primary: Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59…
N/A N=2 Safety of 4CMenB Exposure During Pregnancy
Infections, Meningococcal
Primary: Major Congenital Malformation (MCM)
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
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=306 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
Group B Streptococcus Infections
Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination — 39.2; 45.9; 33.0; 27.5 Percentage of participants
Phase 4 N=18 Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)
Meningococcal Infections
Primary: Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers — 93 percentage…
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