
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered...
Meningococcal DiseaseMeningococcal MeningitisThe 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). In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.

Optimising Diagnosis and Antibiotic Prescribing for Acutely Ill Children in Primary Care
SepsisBacteraemia8 moreAcute illness is the most common presentation of children attending ambulatory care settings. Serious infections (e.g. meningitis, sepsis, pyelonephritis, pneumonia) are rare, but their impact is quite large (increased morbidity, mortality, induced fear in parents and defensive behaviour in clinicians). Early recognition and adequate referral of serious infections are essential to avoid complications (e.g. hearing loss after bacterial meningitis) and their accompanied mortality. Secondly, we aim to reduce the number of investigations, referrals, treatments and hospitalisations in children who are diagnosed with a non-serious infection. Apart from the cost-effectiveness, this could lead to less traumatic experiences for the child and less fear induction for the concerned parent. Finally, we aim to support the clinicians to rationalise their antibiotic prescribing behaviour, resulting in a reduction of antibiotic resistance in the long run.

A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
Meningococcal InfectionMeningitisThe purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. To describe the safety profile of participants after one dose of Menactra®.

A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
MeningitisMeningococcalThe purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines...
Meningococcal InfectionsMeningococcal MeningitisSafety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Immunogenicity: To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.

Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers...
MeningitisMeningococcal InfectionThis study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers. Primary Objectives: Safety and Immunogenicity: To describe the safety and immunogenicity profiles of: A single dose of each formulation of TetraMen-T vaccine A single dose of NeisVac-C® vaccine.

Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier...
MeningitisMeningococcemiaStudy will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants. Objectives: To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26. To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects. To describe the safety profile of a single dose of Menactra® vaccine in subjects.

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster...
Meningococcal DiseaseMeningococcal MeningitisThis 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 different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
MeningitisMeningococcal1 morePrimary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.

Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized...
Neisseria Meningitidis (Bacterial Meningitis)Invasive Pneumococcal Disease (IPD)The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infancy is to demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone, and does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.