Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of...
Meningococcal DiseaseMeningococcal MeningitisThis study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.
Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001
MeningitisThe clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines...
MeningitisMeningococcal DiseaseThis aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines. Primary Objective: To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
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.
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at...
Meningococcal DiseaseMeningococcal MeningitisThe 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 (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
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.
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel...
Meningococcal DiseaseMeningococcal Meningitis4 moreThis study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
MeningitisMeningococcalOut of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet. Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5). The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues. This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®). Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose. The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).
A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals'...
MeningitisMeningococcalMenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries. The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.
Ciprofloxacin for the Prevention of Meningococcal Meningitis
MeningitisMeningococcalThis study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic. One third of enrolled villages will receive standard care; in one-third of villages, household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin; and in one-third of villages, the entire village will be offered a single dose of oral ciprofloxacin after the notification of the first case in the village.