Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by...
MeningitisMeningococcal1 moreClinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).
Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents
Meningococcal DiseaseMeningococcal MeningitisThe purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After...
MeningitisMeningococcal Meningitis1 moreThe purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549). Objectives: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination. To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago. To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.
Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine
Meningococcal MeningitisPrimary objective: To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups. Secondary Objectives: To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups Study site:Two rural communities (Kebele) in Butajira district, Ethiopia. Methods: Phase II, open and parallel safety and immunogenicity trial. 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting. Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously. Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination. Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, & 28. Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination. Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23. Results: No significant difference in the incidence of general or local AEFI was observed between the age groups The statistical analysis for the Immunogenicity data is in progress
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously...
Meningococcal MeningitisThe primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate...
Meningococcal MeningitisThe primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal...
Meningococcal DiseaseMeningococcal MeningitisImmunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged...
Meningococcal MeningitisTo compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers...
MeningitisMeningococcalThe purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 35 years.
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate...
MeningitisMeningococcal Meningitis1 moreThe aim of the study is to assess the safety of Menactra vaccine in infants, toddlers, children, adolescents, and adults Objective: To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in participants aged 9 months to 55 years for registration.