View clinical trials related to Streptococcal Infections.
Filter by:This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).
This study will evaluate whether babies are more at risk of developing breathing problems if their mothers carry group B streptococci (GBS) in vagina/rectum, and whether the breathing problem is due to phospholipids released by the GBS. About one in five pregnant women carry GBS in their vagina/rectum. Mothers who carry these bacteria are given antibiotics during labor to prevent infection in the baby. However, recently it has been suspected that even without blood stream infection, the chemicals released by GBS, called phospholipids, might lead to breathing problems. Women at 32 or more weeks of pregnancy who deliver at Ben Taub Hospital and St. Luke s Episcopal Hospital in Houston, Texas, and Alta Bates Summit Medical Center in Oakland, California, may be eligible for this study. Mothers undergo the following procedures: - Vaginal/rectal GBS culture. A sample is collected from the lower vagina and rectum using a cotton swab upon admission to labor and delivery. - Blood collection to test for phospholipids. A blood sample is obtained from the mothers at the time of routine blood drawing during labor, and a blood sample is obtained from the umbilical cord (after delivery). - Collection of health information from the medical record. Newborns undergo the following procedures: - GBS culture. Samples are collected from cotton swabs of the ears, navel, anus and throat to test for GBS bacteria. - A small amount of blood from newborns is obtained for phospholipids test when the newborns have blood drawn for other tests. - Collection of health information from the medical record.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)
This is a study to to compare traditional fibre wound swabs to more recently developed flocked swabs for the identification of Group A streptococcal pharyngitis in children presenting to a children's emergency department.
GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (cSSSI) have been completed. The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI. Data from animals support this theory. SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a second dose on Day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612). This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.