Blood
01 Jan 2013
A Study Evaluating Safety and Immunogenicity of Meningococcal B rLP2086 Vaccine in Adolescents
The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18…
Blood
01 Jan 2013
Treatment of Deficient Subclass or Anti-Polysaccharide Antibody Response (Subklasse)
There is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. Therefore, the Dutch Inter University Working Party will start a study in which the treatment with antibiotics is compared with intravenous immunoglobulin therapy with respect to clinical…
Gastro
01 Jan 2013
Truvada Versus Truvada Plus HBIG in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this study is to evaluate the safety and antiviral efficacy of the combination therapy (emtricitabine/tenofovir disoproxil fumarate), plus or minus Hepatitis B Immunoglobulin (HBIG) in preventing the recurrence of chronic hepatitis B after a patient (who was chronically infected with hepatitis B pre-liver transplant) has undergone a…
Children's health
01 Jan 2013
Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children
The purpose of this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and…
Children's health
01 Jan 2013
Treatment of Children With Obstructive Sleep Apnoea and Laryngomalacia: The Role of Laser Supraglottoplasty
This is a research study of the effect of treating laryngomalacia (floppiness of tissue on top of the voice box that can possibly block breathing) found in association with obstructive sleep apnoea (blockage of breathing while sleeping). The purpose of this study is to determine which is the best treatment…
Children's health
01 Jan 2013
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
Objective:Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children. Official Title Conditions Pertussis Whooping Cough Study Type Interventional Study Design Treatment, Randomized. Further Details Protocol Outline: This is a randomized, multicentre study. Patients are…
Children's health
01 Jan 2013
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Primary aim:To evaluate the efficacy of Pulmonarom in the decrease of interleukin-4/interferon gamma after second period of treatment.Secondary aims:To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment.To evaluate loss of working…
Children's health
01 Jan 2013
Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
This is an open, randomised, multicentre clinical trial.Objectives:To describe the safety profiles during the 21 days following each primary and booster injection.To describe the immune response 21 days after each primary and booster injection of each formulation.To describe the antibody persistence after the first vaccination. Official Title Conditions Influenza…
Children's health
01 Jan 2013
Evaluation Of Valaciclovir In Patients With Chickenpox
This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox. Official Title Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox…