Clinical trials: Prevention of the Meningococcal Disease
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
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
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 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
Infections, Meningococcal
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™.
- Trial name
- NCT00291343
- Testing
- Tritanrix™- HepB, Hiberix™, Mencevax™ ACWY
- Where
- 2 sites in Philippines
- Volunteers
- 296 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
- Trial name
- NCT00661713
- Testing
- rMenB+OMV NZ
- Where
- 10 sites in Chile
- Volunteers
- 1,631 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Prevention of Meningococcal Disease
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy infants.
- Trial name
- NCT00262002
- Testing
- MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation), MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation), MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
- Where
- 3 sites in Canada, United Kingdom
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Prevention of Meningococcal Disease
Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to…
- Trial name
- NCT00262041
- Testing
- MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY-CRM conjugate vaccine, unadjuvanted, MenACWY polysaccharide vaccine
- Where
- 3 sites in United States
- Volunteers
- 524 people
- Sponsor
- Novartis Vaccines
Meningococcal Disease, Meningococcal Meningitis
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
This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two…
- Trial name
- NCT00944034
- Testing
- rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ, two doses of rMenB+OMV NZ
- Where
- 72 sites in Belgium, Czechia and 4 more
- Volunteers
- 1,588 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease
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
The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and…
- Trial name
- NCT01026974
- Testing
- rMenB, rMenB+OMV NZ
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infections, Meningococcal
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the…
- Trial name
- NCT00317109
- Testing
- Tritanrix™- HepB, Hiberix™, Mencevax™ ACW
- Where
- 3 sites in South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
- Trial name
- NCT00433914
- Testing
- rMenB, rMenB+OMV
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Infections
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects…
- Trial name
- NCT00721396
- Testing
- rMenB+OMV NZ, combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine, Pneumococcal vaccine
- Where
- 60 sites in Belgium, Czechia and 4 more
- Volunteers
- 1,885 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease
B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific…
- Trial name
- NCT00488683
- Testing
- MenACWY-CRM, DTaP-Hib-IPV, PCV
- Where
- United Kingdom
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Prevention of the Meningococcal Disease
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.
The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
- Trial name
- NCT01911221
- Testing
- rMenB+OMV NZ
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Prevention of Meningococcal Disease
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years
- Trial name
- NCT00262028
- Testing
- MenACWY-CRM Vaccine, MenACWY-PS Vaccine
- Where
- United States
- Volunteers
- 910 people
- Sponsor
- Novartis Vaccines
Meningococcal Disease
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
The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose…
- Trial name
- NCT00847145
- Testing
- 1a - rMenB+OMV NZ and routine vaccines, 1b - rMenB+OMV NZ and routine vaccines, 2a - Routine and rMenB+OMV NZ vaccines
- Where
- 59 sites in Austria, Czechia and 3 more
- Volunteers
- 2,249 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Infections
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
- Trial name
- NCT00616421
- Testing
- MenACWY-CRM, Licensed meningococcal ACWY vaccine
- Where
- 68 sites in United States, Canada
- Volunteers
- 2,907 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease, Meningococcal Meningitis
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.
- Trial name
- NCT01434680
- Testing
- MenC-CRM LIQ, MenC-CRM ROS, MenC-CRM EMV
- Where
- 11 sites in Poland
- Volunteers
- 992 people, healthy volunteers welcome
- Sponsor
- Novartis