Clinical trials: Meningococcal B Disease
Gonorrhoea
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae…
- Trial name
- NCT04722003
- Testing
- Meningococcal Group B Vaccine
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.
- Trial name
- NCT00381615
- Testing
- rMenB, rMenB+OMV, DTaP-Hib-IPV
- Where
- 3 sites in United Kingdom
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.
- Trial name
- NCT00161928
- Testing
- Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
- Where
- 14 sites in Austria, Germany
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Pfizer
Meningitis, Meningococcal
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease
- Trial name
- NCT00297687
- Testing
- MnB rLP2086
- Where
- 3 sites in Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Gonorrhea, Meningococcal Disease
Immunisation for Adolescents Against Serious Communicable Diseases (B Part of it NT)
This study aims to implement a targeted 4CMenB immunisation program in young people aged 14-19 years in the Northern Territory (NT).
- Trial name
- NCT04398849
- Testing
- Licenced 4CMenB Vaccine
- Where
- Australia
- Volunteers
- 7,100 people, healthy volunteers welcome
- Sponsor
- University of Adelaide
Meningococcal Disease
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
One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.
- Trial name
- NCT01139021
- Testing
- rMenB+OMV NZ
- Where
- 19 sites in Czechia, Finland
- Volunteers
- 508 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Splenectomy; Status
Meningococcal B Vaccine in Patients with Asplenia
Patients without a spleen (asplenia) experience an increased risk for septicaemia from encapsulated bacteria, which is associated with a high mortality rate.
- Trial name
- NCT06025487
- Testing
- Bexsero
- Where
- Austria
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Haemophilus Influenzae Type b, Neisseria Meningitidis
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year…
- Trial name
- NCT00326118
- Testing
- Haemophilus influenzae type b and meningococcal serogroup C (vaccine), Priorix™, Hiberix™
- Where
- 7 sites in Australia
- Volunteers
- 433 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease, Meningococcal Meningitis
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
- Trial name
- NCT01478347
- Testing
- Recombinant meningococcal B + OMV NZ
- Where
- Italy
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis
Investigating the Immune Response to 4CMenB in Infants
This randomised, open-label, single-centre, descriptive study aims to investigate gene expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB and to relate this to vaccine reactions and to…
- Trial name
- NCT02080559
- Testing
- 4CMenB
- Where
- United Kingdom
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Meningococcal Disease
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement…
- Trial name
- NCT02141516
- Testing
- rMenB+OMV
- Where
- 20 sites in Italy, Poland and 3 more
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Novartis
Infectious Diseases
Baby Vaccine Study (Sched3)
This multicentre, parallel group, block randomised clinical trial aims to investigate the post booster antibody response in UK infants given a reduced priming schedule of meningococcal serogroup B vaccine and 13 valent…
- Trial name
- NCT02482636
- Testing
- DTaP/IPV/Hib vaccine, 13 valent Pneumococcal Conjugate Vaccine, Rotavirus vaccine
- Where
- United Kingdom
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Meningococcal Disease, Meningococcal Meningitis
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers…
- Trial name
- NCT01423084
- Testing
- Serogroup B meningococcal vaccine
- Where
- 13 sites in Australia, Canada
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningococcal B Disease
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.
- Trial name
- NCT02534935
- Testing
- rLP2086 vaccine, Pediatric HAV vaccine
- Where
- 25 sites in Australia, Czechia and 2 more
- Volunteers
- 396 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design.
- Conditions
- Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis, Haemophilus Influenzae Type B Infection
- Trial name
- NCT07203755
- Testing
- Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4), DTcP-Hib-MCV4, Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)
- Where
- China
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Meningitis, Meningococcal Infection
Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
The aim of the study is to further characterize the safety and immunogenicity of Menactra® in the population <2 years of age when administered alone and when the second dose is administered concomitantly with the 4th dose of…
- Conditions
- Meningitis, Meningococcal Infection, Diphtheria, Tetanus
- Trial name
- NCT01659996
- Testing
- Meningococcal polysaccharide diphtheria toxoid conjugate, Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
- Where
- 58 sites in United States, Puerto Rico
- Volunteers
- 1,394 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
- Trial name
- NCT00560313
- Testing
- Men ACWY CRM, 4CMenB
- Where
- Italy
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Vaccine, rLP2086
A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.
This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax.
- Conditions
- Meningococcal Vaccine, rLP2086, Repevax, N Meningitidis Serogroup B
- Trial name
- NCT01323270
- Testing
- rLP2086, Repevax, Saline
- Where
- 36 sites in Finland, Germany and 1 more
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tetanus, Hepatitis B
Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted…
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis
- Trial name
- NCT00197275
- Testing
- Hib-MenAC mixed with Tritanrix™-HepB
- Where
- 3 sites in Thailand
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
The purpose of this study is to assess the safety and immune responses of rMenB+OMV NZ vaccine when administered to healthy infants from 2 months in the Republic of Korea according to a 2-dose primary schedule and 1 booster dose.
- Trial name
- NCT06113198
- Testing
- rMenB+OMV NZ
- Where
- 8 sites in South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline