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Infections, Streptococcal clinical trials

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NCT ID: NCT02838407 Completed - Clinical trials for Infections, Streptococcal

Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.

Start date: September 23, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is indicated by the clinician.

NCT ID: NCT02447432 Completed - Clinical trials for Infections, Streptococcal

A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants

Start date: June 11, 2015
Phase: Phase 3
Study type: Interventional

The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first secondary objective), after administration of a 3-dose primary vaccination course at 6, 10 and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at 6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule). In addition, the study will also assess the safety, reactogenicity, immunogenicity and antibody persistence (approximately 7 months following primary vaccination) of the 4-dose presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18 weeks of age followed by a booster dose at 38 weeks. This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9 months of age.

NCT ID: NCT02270944 Completed - Clinical trials for Infections, Streptococcal

Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine

Start date: November 20, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.

NCT ID: NCT01793857 Completed - Clinical trials for Infections, Streptococcal

Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama

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

The study is a survey aiming to describe the healthcare seeking behaviour of primary caregivers when their child aged 6 months to less than 30 months was suspected to have an episode of acute otitis media in Panama.

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: NCT01641133 Completed - Clinical trials for Infections, Streptococcal

Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

Start date: September 4, 2012
Phase: Phase 3
Study type: Interventional

The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

NCT ID: NCT01616459 Completed - Clinical trials for Infections, Streptococcal

Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

Start date: July 11, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.

NCT ID: NCT01545375 Completed - Clinical trials for Infections, Streptococcal

Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children

Start date: May 21, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

NCT ID: NCT01485406 Completed - Clinical trials for Infections, Streptococcal

Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers

Start date: December 12, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.

NCT ID: NCT01365390 Completed - Clinical trials for Infections, Streptococcal

To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries

Start date: June 2011
Phase: N/A
Study type: Observational

The aim of this study is to provide baseline acute otitis media data in East European countries.