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Meningococcal Disease

44
Pipeline Programs
4
Companies
46
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
17
4
21
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
21100%
+ 60 programs with unclassified modality

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
39 programs
14
3
18
1
MeningococcalPhase 4
1 dose of MeningococcalPhase 3
1a - rMenB+OMV NZ and routine vaccinesPhase 3
Bexsero®Phase 3
MenACWY-CRMPhase 3
+34 more programs
Active Trials
NCT01434680Completed992Est. Nov 2012
ViiV Healthcare
ViiV HealthcareNC - Durham
10 programs
3
1
3
1
MenACWY-CRMPhase 4
Bexsero®Phase 3
MenACWY-CRMPhase 3
MenACWY-CRMPhase 3
rMenB+OMV NZ with routine vaccinationsPhase 2/3
+5 more programs
Novartis
NovartisBASEL, Switzerland
24 programs
MenACWY-CRMN/A1 trial
MenACWY-CRMN/A1 trial
Novartis Meningococcal ACWY Conjugate VaccineN/AVaccine1 trial
Men ACWY CRMPHASE_21 trial
MenABCWYPHASE_22 trials
+19 more programs
Active Trials
NCT01452464Completed55,397Est. Feb 2015
NCT01452438Completed393Est. Jul 2015
NCT01705379Withdrawn0Est. Apr 2016
+29 more trials
GSK
GSKLONDON, United Kingdom
8 programs
Meningococcal quadrivalent CRM-197 conjugate vaccineN/AVaccine1 trial
Meningococcal quadrivalent CRM-197 conjugate vaccineN/AVaccine1 trial
MenABCWY+OMV vaccinePHASE_2Vaccine1 trial
rMenB+OMV NZ with routine vaccinationsPHASE_2_3
Bexsero®PHASE_3
+3 more programs
Active Trials
NCT02223637Completed93Est. Dec 2017
NCT02287688Completed144Est. Nov 2017
NCT02451514Completed129Est. Dec 2015
+2 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
NovartisMeningococcal
GSKMenACWY-CRM
NovartisrMenB+OMV NZ
NovartisBexsero®
NovartisrMenB
NovartisrMenB+OMV NZ
NovartisrMenB+OMV NZ
NovartisRecombinant meningococcal B + OMV NZ
Novartis1 dose of Meningococcal
NovartisMenACWY-CRM
GSKMenACWY-CRM
NovartisTyphoid Vi Polysaccharide Vaccine
NovartisMenACWY-CRM
NovartisSerogroup B meningococcal vaccine
NovartisMenACWY-CRM

Showing 15 of 46 trials with date data

Clinical Trials (46)

Total enrollment: 85,780 patients across 46 trials

NCT01823536NovartisMeningococcal

Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose

Start: May 2013Est. completion: Jun 2014465 patients
Phase 4Completed
NCT01766206GSKMenACWY-CRM

Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea

Start: Mar 2013Est. completion: Jan 20183,948 patients
Phase 4Completed

Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

Start: Dec 2014Est. completion: Apr 201555 patients
Phase 3Completed

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.

Start: Sep 2014Est. completion: Jun 2016225 patients
Phase 3Completed

Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

Start: May 2014Est. completion: Mar 2015239 patients
Phase 3Completed

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

Start: Nov 2013Est. completion: Apr 2014264 patients
Phase 3Completed

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.

Start: Aug 2013Est. completion: Apr 201413 patients
Phase 3Completed
NCT01478347NovartisRecombinant meningococcal B + OMV NZ

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

Start: May 2013Est. completion: Nov 201418 patients
Phase 3Completed
NCT01717638Novartis1 dose of Meningococcal

Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

Start: Nov 2012Est. completion: Oct 2013805 patients
Phase 3Completed

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

Start: Nov 2012Est. completion: Mar 2013198 patients
Phase 3Completed
NCT01682876GSKMenACWY-CRM

Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

Start: Oct 2012Est. completion: May 2014715 patients
Phase 3Completed
NCT01466387NovartisTyphoid Vi Polysaccharide Vaccine

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults

Start: Nov 2011Est. completion: Apr 2012552 patients
Phase 3Completed

Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine

Start: Oct 2011Est. completion: Jan 2012252 patients
Phase 3Completed
NCT01423084NovartisSerogroup B meningococcal vaccine

Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

Start: Aug 2011Est. completion: Dec 2011344 patients
Phase 3Completed

Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

Start: May 2011Est. completion: Sep 2011205 patients
Phase 3Completed

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

Start: Apr 2011Est. completion: Dec 20141,409 patients
Phase 3Completed

Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

Start: Oct 2010Est. completion: May 2012751 patients
Phase 3Completed

Novartis Vaccine and Diagnostics Carriage Trial

Start: Sep 2010Est. completion: Jan 20122,968 patients
Phase 3Completed

One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

Start: Jun 2010Est. completion: Sep 2011508 patients
Phase 3Completed

A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

Start: Nov 2009Est. completion: Nov 2011529 patients
Phase 3Completed

Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

Start: Feb 2009Est. completion: Aug 20102,249 patients
Phase 3Completed

Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Start: Mar 2008Est. completion: Jan 20103,630 patients
Phase 3Completed
NCT00329849NovartisMeningococcal ACWY-CRM conjugate vaccine

Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

Start: May 2006Est. completion: Mar 20071,500 patients
Phase 3Completed

Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

Start: Aug 2010Est. completion: Jan 2012817 patients
Phase 2/3Completed

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

Start: Jul 2009Est. completion: Jan 20121,588 patients
Phase 2/3Completed

Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

Start: Jun 2008Est. completion: Dec 20101,631 patients
Phase 2/3Completed
NCT02451514GSKMenABCWY+OMV vaccine

A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)

Start: Jun 2015Est. completion: Dec 2015129 patients
Phase 2Completed

Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Start: May 2014Est. completion: Feb 2015305 patients
Phase 2Completed

Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)

Start: Dec 2013Est. completion: Apr 2015194 patients
Phase 2Completed

Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

Start: Nov 2013Est. completion: Oct 2014202 patients
Phase 2Completed
NCT01434680SandozMenC-CRM LIQ

Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers

Start: Sep 2011Est. completion: Nov 2012992 patients
Phase 2Completed

Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines

Start: Jul 2011Est. completion: Jul 2012440 patients
Phase 2Completed

Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

Start: Dec 2010Est. completion: Jul 2011495 patients
Phase 2Completed

Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine

Start: Feb 2010Est. completion: May 2012120 patients
Phase 2Completed

Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine

Start: Jan 2010Est. completion: May 2012163 patients
Phase 2Completed
NCT01018732NovartisNovartis Meningococcal

A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

Start: Jan 2010Est. completion: Jul 2010155 patients
Phase 2Completed

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

Start: Jul 2007Est. completion: Nov 200954 patients
Phase 2Completed

B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

Start: Jul 2007Est. completion: Jun 2009216 patients
Phase 2Completed

Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

Start: Feb 2007Est. completion: Jul 200860 patients
Phase 2Completed

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Start: Sep 2006Est. completion: Aug 2008147 patients
Phase 2Completed
NCT00297817Novartisserogroup B meningococcal vaccine

Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents

Start: Feb 2006Est. completion: Apr 2007203 patients
Phase 2Completed
NCT02287688GSKMeningococcal quadrivalent CRM-197 conjugate vaccine

Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Start: Dec 2014Est. completion: Nov 2017144 patients
N/ACompleted
NCT02223637GSKMeningococcal quadrivalent CRM-197 conjugate vaccine

Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

Start: Sep 2014Est. completion: Dec 201793 patients
N/ACompleted
NCT01705379NovartisNovartis Meningococcal ACWY Conjugate Vaccine

Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older

Start: Mar 2013Est. completion: Apr 20160
N/AWithdrawn

Safety of MenACWY-CRM Vaccination in Adolescents

Start: Sep 2011Est. completion: Feb 201555,397 patients
N/ACompleted

Safety Surveillance of MenACWY-CRM Vaccine in Children

Start: Sep 2011Est. completion: Jul 2015393 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

21 late-stage (Phase 3) programs, potential near-term approvals
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.