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Streptococcal Infections clinical trials

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NCT ID: NCT00839254 Completed - Clinical trials for Infections, Streptococcal

Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

Start date: February 18, 2009
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442. The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

NCT ID: NCT00829010 Completed - Clinical trials for Infections, Streptococcal

Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.

Start date: February 17, 2009
Phase: Phase 3
Study type: Interventional

The purposes of this study: - To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age and following booster vaccination at 9-10 months of age. - To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at 6 and 14 weeks of age followed by booster vaccination at 9-10 months of age. - This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all study participants.

NCT ID: NCT00814710 Completed - Clinical trials for Infections, Streptococcal

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

Start date: March 7, 2009
Phase: Phase 3
Study type: Interventional

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 Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

NCT ID: NCT00808444 Completed - Clinical trials for Infections, Streptococcal

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

Start date: January 5, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.

NCT ID: NCT00792909 Completed - Clinical trials for Infections, Streptococcal

Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

Start date: December 2, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children. The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life. The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life. 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 = 00307034)

NCT ID: NCT00756067 Completed - Clinical trials for Infections, Streptococcal

Evaluation of Pneumococcal Vaccine Formulations in Elderly

Start date: September 19, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.

NCT ID: NCT00707798 Completed - Clinical trials for Infections, Streptococcal

Evaluation of Pneumococcal Vaccine Formulations in Young Adults

Start date: June 30, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months.

NCT ID: NCT00680914 Completed - Clinical trials for Infections, Streptococcal

Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™

Start date: June 10, 2008
Phase: Phase 3
Study type: Interventional

The purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life. To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.

NCT ID: NCT00678301 Completed - Clinical trials for Infections, Streptococcal

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

Start date: June 18, 2008
Phase: Phase 3
Study type: Interventional

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 African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

NCT ID: NCT00652951 Completed - Clinical trials for Infections, Streptococcal

Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib

Start date: April 1, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.