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Meningitis clinical trials

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NCT ID: NCT02080559 Completed - Meningitis Clinical Trials

Investigating the Immune Response to 4CMenB in Infants

Start date: July 21, 2014
Phase: Phase 4
Study type: Interventional

This randomised, open-label, single-centre, descriptive study aims to investigate gene expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB and to relate this to vaccine reactions and to immune response. 160 healthy Caucasian infants aged 8-12 weeks (at time of first visit) who have not yet received their routine infant immunisations will be recruited. Participation in the study will be limited to to Caucasian infants (defined as having two Caucasian parents). This is so that baseline variability in gene expression data which is to some degree affected by ethnicity is reduced. Participants will be randomised to either a 'test' group or 'control' group depending on what 4CMenB schedule they receive, with 80 infants in each. All participants will receive the usual paediatric immunisations according to the UK national immunisation schedule. In addition, participants in the test groups will receive 4CMenB at 2, 4 and at 12 months while those in the control groups will receive the same vaccine at 5, 7 and 13 months. Blood samples will be taken from each infant at specified time points before and after vaccination to address the objectives of the study. In addition, oro-pharyneal swabs will be obtained around different vaccination timepoints to investigate the effect of 4CMenB vaccination on the oro-pharyngeal Neisseria microbiome.

NCT ID: NCT02054091 Completed - Sepsis Clinical Trials

Feeding Bovine Colostrum to Preterm Infants

PreColos
Start date: February 2014
Phase: N/A
Study type: Interventional

Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered as the best for the digestive system followed by donor milk. Preterm infant formula is related to more feeding problems and other gut complications in these babies, such as necrotizing enterocolitis. Bovine colostrum contains higher amounts of protein, growth factors and immuno-regulatory components (e.g. immunoglobulins), which has been used in many other situations to promote health. The investigators plan to give bovine colostrum to preterm infants with birth weights between 1000 and 1800 g, or born between 27+0 and 32+6 weeks of gestational age, in order to promote feeding and intestinal health in these babies. This current study is a feasibility pilot study and the investigators hypothesized that supplementing BC to MM (if available) is safe and tolerable when used within the first 10-14 days of life in preterm infants.

NCT ID: NCT02024282 Completed - Sepsis Clinical Trials

Optimising Diagnosis and Antibiotic Prescribing for Acutely Ill Children in Primary Care

ERNIE2
Start date: January 2013
Phase: N/A
Study type: Interventional

Acute 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.

NCT ID: NCT02003495 Completed - Meningitis Clinical Trials

Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.

NCT ID: NCT02003313 Completed - Meningitis Clinical Trials

Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

Start date: November 2013
Phase: Phase 3
Study type: Interventional

The purpose of this double-blind study is to evaluate the safety, reactogenicity and immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30 years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine.

NCT ID: NCT01996007 Completed - Pneumonia Clinical Trials

Understanding Pneumococcal Carriage and Disease

Start date: March 2014
Phase:
Study type: Observational

Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and middle ear infections), blood poisoning, and meningitis. It is frequently carried by people in back of the throat without symptoms. Pneumococcal carriage in the Thames Valley region has been studied over the last 12 years with carriage rates having been shown to be reflective of disease potential and hence vaccine effect. During this time pneumococcal vaccines have been introduced into the routine immunisation schedules of this community. The PCV7 (A vaccine against 7 types of pneumococcus) vaccine has subsequently been noted to have had a significant impact in reducing vaccine serotype carriage and disease. Herd protection (indirect protection of unvaccinated individuals) has also been implicated with vaccine serotypes not being carried in parents of vaccinated children. The most common serotype carried since the introduction of PCV7 is 19A, which is included in the PCV13 vaccine (A vaccine against 13 types of pneumococcus). PCV13 has superseded PCV7 in the routine immunisation schedule, however its impact on carriage and disease in this community is yet to be evaluated.

NCT ID: NCT01904448 Completed - Cochlear Aplasia Clinical Trials

Auditory Brainstem Implantation in Young Children

Start date: September 2012
Phase: N/A
Study type: Interventional

To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or cochlear nerve disorders. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or cochlear malformation. This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24 Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure, tolerance of device stimulation, and the potential for auditory benefit beyond that experienced with their CI. This study will provide the preliminary experience for a larger scale clinical trial. Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development of sound awareness and improved speech understanding among children implanted with the ABI when compared to their baseline skills. Aim 3: Demonstrate the development of oral language skills following the use of the ABI that were not evident prior to its use.

NCT ID: NCT01897402 Completed - Clinical trials for Meningococcal Meningitis

Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Start date: July 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the production of antibodies to a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135) polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The hypothesis is that the test vaccine is comparable to the licensed active control vaccine.

NCT ID: NCT01894919 Completed - Clinical trials for Meningococcal Meningitis

Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72_28 study.

NCT ID: NCT01890759 Completed - Meningitis Clinical Trials

Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

Start date: June 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: - To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart. Secondary Objectives: - To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers. - To assess the safety profile of Menactra® after each and any vaccination.