View clinical trials related to Meningococcal Disease.
Filter by:A fever and a non-blanching rash is a relatively common reason for a child to attend an emergency department. A fever and a non-blanching rash can be an early sign of a life-threatening infection known as meningococcal disease. The aim of the PIC study is to determine how best to diagnose early meningococcal disease in children. In particular the investigators are interested in researching how quick bedside tests can be used to do this.
In the UK, babies receive their vaccinations according to a standard schedule, irrespective of their gestation at birth. This policy is designed so that all babies are protected as early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus, rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK schedule in September 2015 and there has been no research looking at whether the vaccine gives the same protection to babies born early as it does to those born at term. The Investigators want to compare two different schedules of 4CMenB and see if one gives better protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three doses in early infancy instead of two) will offer better protection for premature babies. This is what the Investigators are trying to find out through this study.
To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.
A previous cohort of 93 clinical trial participants received quadrivalent meningococcal conjugate vaccine, which includes strains ACW and Y, in their teenage years. The vaccine also contains components of diphtheria and tetanus which are linked to the meningitis components, in a process called conjugation, to improve their effectiveness. Participants are now aged 19-25 and will be invited to take part in this study, which will assess antibody persistence over time. This will provide information about the duration of protection by relating current antibody levels to those measured in the previous study, and will underpin the national immunisation schedule in providing optimal immunisation schedule. As well as the meningitis antibodies the investigators will assess diphtheria and tetanus antibody levels. The study will involve a single blood test of up to 8mL. Participants will be informed of their results and any with an antibody level that does not infer protection against strain W will be offered an extra dose of vaccine as part of a duty of care. The study will involve a single blood test of up to 8mL. Participants will be informed of their results and any with an antibody level that does not infer protection against strain W will be offered an extra dose of vaccine.
The purpose of this study is to evaluate persistence of bactericidal antibodies for N. meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years after primary vaccination in subjects who previously received a 2-dose series of MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a 2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive subjects and subjects who previously received one dose of MenACWY
This safety surveillance study of GlaxoSmithKline's quadrivalent meningococcal ACWY conjugate vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a post-marketing study required by the United States Food and Drug Administration. It is an observational study of children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled as a KPSC health plan member. The objective of the infant study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization in the United States. Outcomes include medical events that require emergency room visits or hospitalizations in children 2-23 months of age following any dose of MenACWY-CRM vaccination. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a pre-existing condition.
This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be invited at the time of their last study visit to participate in this extension study.
The GlaxoSmithKline's Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is established to meet a post marketing commitment agreed upon with CBER to prospectively collect data on pregnancy exposures to Meningococcal quadrivalent CRM-197 conjugate vaccine. It is an observational study of women inadvertently immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy as part of routine care. The objective of the pregnancy registry is to evaluate pregnancy outcomes among women immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.
Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.
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 deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.