Clinical Trials Logo

Meningitis clinical trials

View clinical trials related to Meningitis.

Filter by:

NCT ID: NCT01430611 Completed - Meningitis Clinical Trials

Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age. Primary Objective: To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine. Secondary Objective: - To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose. - To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.

NCT ID: NCT01428908 Completed - Clinical trials for Type b Haemophilus Influenza

Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children

Start date: September 2011
Phase: Phase 3
Study type: Interventional

Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming. Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration. According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections. After the phase I study which was conducted in August, 2011, the safety profile of this vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.

NCT ID: NCT01424644 Completed - Clinical trials for Meningococcal Meningitis

A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents

Start date: September 2011
Phase: Phase 4
Study type: Interventional

The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck & Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone.

NCT ID: NCT01423084 Completed - Clinical trials for Meningococcal Disease

Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The 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.

NCT ID: NCT01410474 Completed - Clinical trials for Bacterial Meningitis

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

Start date: August 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.

NCT ID: NCT01396798 Completed - Sepsis Clinical Trials

Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.

ERNIE3
Start date: February 2011
Phase: N/A
Study type: Observational

Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.

NCT ID: NCT01373710 Completed - Clinical trials for Metastatic Breast Cancer

Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis

HIT
Start date: May 19, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is: Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL) near the conventional therapeutic concentration and depending on the dose-limiting toxicity (DLT) Phase II: Determination of antitumor activity trastuzumab when administrated by IT or intra-ventricular in terms of neurological progression-free survival at 2 months

NCT ID: NCT01371916 Completed - Clinical trials for Tuberculous Meningitis

Diagnosis of Tuberculous Meningitis by ESAT-6 in CSF

Start date: September 2010
Phase: N/A
Study type: Observational

Early and reliable diagnosis of tuberculous meningitis (TBM) still poses a great challenge. One of the underlying difficulties is due to the fact that tubercle bacilli are mainly not present in the cerebrospinal fluid (CSF) but in the phagocytotic macrophages. The present study was designed to demonstrate early secretory antigenic target 6 (ESAT-6), a mycobacterium-specific antigens, in the macrophages in infected CSF samples and compare the efficiency of this antigen in the laboratory diagnosis of TBM.

NCT ID: NCT01367158 Completed - Clinical trials for Meningococcal Disease

Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines

Start date: July 2011
Phase: Phase 2
Study type: Interventional

This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.

NCT ID: NCT01359449 Completed - Meningitis Clinical Trials

Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

Start date: May 2011
Phase: Phase 3
Study type: Interventional

The purpose for this study is to demonstrate the safety and immunogenicity of two doses of Menactra® administered between 12 and 18 months of age and concomitantly with routine immunization with two different provincial schedule Primary Objectives: - To describe the immunogenicity of Menactra® administered concomitantly with routine immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants (measured by serum bactericidal assay using baby rabbit complement [SBA-BR]) - To describe the immunogenicity of MenC administered concomitantly with routine immunizations at 12 months of age (measured by SBA-BR) Secondary Objectives: Safety - To describe the safety profile of Menactra® and MenC vaccines after each dose when given concomitantly with routine immunization. Immunogenicity - To describe the immunogenicity of both vaccines using serum bactericidal assay using human complement [SBA-HC] - To describe the immunogenicity of Pediacel administered at 18 months.