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Pneumococcal Infections clinical trials

View clinical trials related to Pneumococcal Infections.

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NCT ID: NCT02037984 Completed - Clinical trials for Pneumococcal Infections

Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)

Start date: January 28, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.

NCT ID: NCT01939522 Completed - Clinical trials for Type 1 Diabetes Mellitus

Protection Against Pneumococcal Infection in Children With T1DM

T1DM
Start date: August 2013
Phase: Phase 4
Study type: Interventional

Children/ young people with diabetes may be at a higher risk of acquiring certain infections. These infections include those caused by a bacterium called the pneumococcus which can cause pneumonia, meningitis and ear infections. In the UK older children with diabetes are given a vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). Although PPS23 causes a good immune response in children over 2 years of age it is not actually known how well PPS23 protects against infection in children of any age. In addition there is some data in adults and children that PPS23 may result in a reduced response to future doses of pneumococcal vaccines (hyporesponsiveness). Because of the lack of information on how well PPS23 protects and potential hyporesponsiveness the investigators would like to study the use of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13). This vaccine is known to be safe and to work well in babies and young children and there have been no concerns about hyporesponsiveness. It has been approved for use in children up to 17 years of age but there is little information on the size and duration of immune response to PCV13 in children aged 6 years and older.

NCT ID: NCT01899365 Completed - Clinical trials for Pneumococcal Infections

An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department

IMPROVED
Start date: November 2015
Phase:
Study type: Observational

Background : Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the 6th cause of death. CAP also frequently associates with other disorders responsible for admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major pathogen that is commonly involved and frequently leads to severe infection and admission. Categories at risk for this pathogen have been determined, and can be proposed anti-pneumococcal vaccination (APV) that efficiently and safely protects from this microorganism. In the context of US health services, monocenter pilot experiences have reported improvement of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk were proposed vaccination at ED. To obtain these results, medical students were specifically trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when physicians were alerted for pneumococcal risk by the software they usually utilized at bedside. However these experiences remain sparse as additional dedicated resources are required or patients and attending ED physicians can be reluctant to proceed to vaccination at ED. Mobile phone and derived communication modalities are current vectors to deliver information in several fields including education and medicine. Initially used in developing countries, short-message services (SMS) have improved behaviour of patients in various medical areas. In France, the investigators have observed that most patients above 50 years of age admitted after ED visit are equipped with mobile phone and can receive alerts by SMS. These observations prompt us to propose a multifaceted procedure to improve APV after ED visit in at-risk patients, combining structured oral interview, written information and SMS as reminders. Purpose : The investigators hypothesized that - a multifaceted intervention to promote anti-pneumococcal vaccination combining a structured oral interview, a written information to patient and his/her general practitioner, and a series of 3 SMS, - improves anti-pneumococcal vaccination at 6 months, - in at-risk patients (65+ years) visiting the emergency department. In order to answer this question, the investigators designed an interventional prospective multicenter randomized study (cluster).

NCT ID: NCT01896596 Completed - Hepatitis b Clinical Trials

Hepatitis B Vaccination in Infants

Infanrix
Start date: July 2013
Phase: Phase 4
Study type: Interventional

In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age, which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae type b (Hib). Infants also routinely receive a meningococcal group C vaccine (MenC) at 3 and 4 months and a 13-valent pneumococcal vaccine (Prevenar13) at 2 and 4 months of age. This study aims to offer infants a 6-in-1 vaccine (Infanrix-Hexa)that also helps protect against hepatitis B alongside the other routine vaccinations in the UK infant immunisation schedule and assess their immune responses to the different vaccines. Hepatitis B virus infects the liver and usually affects adults, but children can be infected through close contact with carriers of the virus. Children with hepatitis B infection may not have symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. Many other countries already use Infanrix-Hexa and this study is being undertaken to help decide whether the UK can do the same. Babies taking part in this study will receive Infanrix-Hexa instead of Pediacel. All other vaccines given will be the same as in the routine schedule but will include one MenC vaccine instead of 2 doses because the UK infant immunisation schedule is soon going to change so that all babies will receive only one MenC vaccine at 3 months of age. There are currently several licensed MenC vaccines that can be given to babies. In order to check whether there are differences in protection, babies taking part will randomly receive one of 3 MenC-containing vaccines: NeisVacC, Menjugate or Menitorix. Studies have already shown that one dose of Neis-Vac or Menjugate given to babies at 3 months provides similar protection against MenC infection as two doses given at 3 and 4 months. Menitorix protects against both Hib and MenC, so babies in the group receiving MenitorixTM will have an extra dose of Hib which is also included in Infanrix-Hexa but might have a lower antibody response to MenC compared to the other two MenC vaccines, although all infants should be well-protected after their 12-month booster vaccinations, which also contain Menitorix.

NCT ID: NCT01834222 Completed - Clinical trials for Pneumococcal Disease

Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Start date: December 2013
Phase: N/A
Study type: Observational

The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean adults in the routine clinical setting, as required for any new drug approved by Korea Food and Drug Administration (KFDA).

NCT ID: NCT01810861 Completed - Clinical trials for Pneumococcal Diseases

Serotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey

Start date: January 4, 2013
Phase:
Study type: Observational

The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae that causes invasive diseases at children and adults in Turkey.

NCT ID: NCT01746108 Completed - Clinical trials for Infections, Streptococcal

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection

Start date: June 18, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having asplenia, splenic dysfunction or complement deficiencies. In addition, this study will include an age-matched control group of healthy children aged 24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in the at-risk population to that of the general, healthy population one month after each pneumococcal vaccination.

NCT ID: NCT01734239 Completed - Clinical trials for Pneumococcal Disease

A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

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

The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease

NCT ID: NCT01692886 Completed - Clinical trials for Pneumococcal Infection

A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

Start date: August 2012
Phase: Phase 3
Study type: Interventional

This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.

NCT ID: NCT01654263 Completed - Clinical trials for Pneumococcal Infection

A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two groups of participants (55 through 74 years of age). First group vaccine naïve participants will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or Group IIB). Blood samples will be obtained at baseline, at one month and six months post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study