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Streptococcus Pneumoniae clinical trials

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NCT ID: NCT01521897 Completed - Clinical trials for Streptococcus Pneumoniae

Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Start date: September 2010
Phase: N/A
Study type: Observational

This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice. This surveillance will specifically focus on the occurrence of the following: 1. Local reactions at the injection site 2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

NCT ID: NCT01425372 Completed - Clinical trials for Streptococcus Pneumoniae

Evaluating Vaccine Responses in Healthy Infants Receiving Their Routine Primary Immunisation According to the Accelerated United Kingdom Schedule at 2, 3 and 4 Months

P13UK
Start date: November 2010
Phase:
Study type: Observational

Streptococcus pneumoniae is a major cause of serious bacterial infections, particularly among young children. Over 30 different types of the pneumococcus germ can cause invasive disease, but 7 types (namely serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) are responsible for around 75% of cases in young children. A pneumococcal conjugate vaccine against these 7 serotypes (PCV7; Prevenar ®, Wyeth Vaccines) was introduced into the UK national immunisation programme in September 2006 and has resulted in a rapid reduction in pneumococcal disease caused by the 7 serotypes among both vaccinated children and older unvaccinated children and adults through herd immunity. By 2009, over half of all invasive pneumococcal cases in young children were caused by six other pneumococcal serotypes (1, 3, 5, 6A, 7F and 19A) that are included in a newly licensed 13 valent pneumococcal vaccine (PCV13; Prevenar 13®, Wyeth Vaccines). In April 2010, PCV13 replaced PCV7 in the UK immunisation programme with the aim of further reducing cases of invasive pneumococcal disease. The antibody responses induced by the 7 serotypes in both PCV13 and PCV7 have been shown to be comparable, but the protection offered by the additional 6 serotypes in PCV13 merits further study. Also, it is possible that the use of PCV13 instead of PCV7 may interfere with immune responses to other vaccines, such as Haemophilus influenzae serotype b (Hib), which are given to infants at the same time as PCV13. The proposed study will aim to collect one blood sample from infants after they receive their routine vaccinations at 2, 3 and 4 months in order to their measure immune responses to routine vaccines. The investigators hope that their results will help us better understand the added protection offered by the 13valent pneumococcal vaccine and ensure that children are adequately protected by the other vaccines they receive.

NCT ID: NCT01308827 Suspended - Clinical trials for Streptococcus Pneumoniae

Costa Rica Epidemiological Study on S. Pneumoniae

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

Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia and pneumococcal meningitis among infants and children worldwide. Knowledge of the epidemiology of pneumococcal disease is essential to assess the potential usefulness of pneumococcal disease usefulness of pneumococcal conjugate immunization. There is a paucity of information regarding pneumococcal disease burden in children in Latin America. Most studies are based on passive microbiology laboratory surveillance that does not capture all invasive disease, thus underestimating the true disease burden. Data from an active surveillance is available from an specific region in Costa Rica, before introduction of universal vaccination with PCV-7. On January 2009, PCV-7 was introduce into the universal vaccination program for all children born after or on September 2008 using a 3+1 regimen therefore there is a possibility to analyze the benefits of the introduction of this vaccine into the universal immunization program. The only effectiveness data from Latin America have been published from Uruguay where a significant decline in the incidence of pneumonias and meningitis was observed following the introduction of PCV-7. This was associated with an increment of serotypes 19A, 1,5 and 7F. Uruguay modify PCV-7 to PCV-13. In Costa Rica on August 2011, PCV-7 was changed for PCV 13. This study will provide information regarding the impact of PCV-7 and PCV-13.

NCT ID: NCT00907777 Completed - Clinical trials for Infections, Streptococcal

Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

Start date: June 23, 2009
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age. Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™. This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

NCT ID: NCT00900978 Active, not recruiting - Clinical trials for Streptococcus Pneumoniae

Impact of the 7 Valent Pneumococcal Conjugate Vaccine (7vPCV) on Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Jordanian Infants

7vPCV
Start date: May 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Nasopharyngeal (NP) colonization of S. pneumoniae in infants is generally acquired at approximately 4-6 months of age. Although there are differences in the prevalence and rank order of serotypes obtained from NP specimens and from those with invasive diseases, pneumococcal nasopharyngeal isolates may reflect the strains circulating in the community and may be used as a marker to predict serotype prevalence of invasive disease and resistance patterns. The information about pneumococcal strains found in Jordanian children and NP-carriage of infants is limited and do not include children living in rural regions. Monitoring serotype distribution is essential for the appropriate application of vaccination. Vaccine use in infants proves to be highly efficacious in the prevention of invasive pneumococcal disease as well as in decreasing the carriage of vaccine serotypes in the nasopharynx of infants which impacted significantly in the long run on otitis media infection and helped decrease the infection rates among contacts of these infants. The result has been a decrease in the pneumococcal infection rate among elderly contacts of these infants and decrease colonization with pneumococci. In order to determine the pneumococcal serotypes which are prevalent among infants attending day care centers (DCCs) in Jordan, a study of these types circulating among infants will be determined over a period of 15 months in 250-300 children attending the DCCs in Ajlun-City by taking 3 NP-swabs, the first before the first vaccine injection in May 2009, the second before the third injection at 10 months of age and the third swab sample is taken at 1 year of age (2-3 months after the last injection with the 7vPCV. The aims of this study were to determine the frequency of NP-carriage and serotype distribution of the strains isolated from infants less than 2 years old, and to get an insight about the coverage of the available and future pneumococcal conjugate vaccines developed for this infectious agent. Good results of this study project would make recommendations for the Ministry of Health (MOH) to include the vaccine in the National Vaccination Program. 15000 doses of the 7v PCV (Prevenar) were donated from Wyeth Pharmaceutical company to the MOH of Jordan in September 2008. These will be vaccinated in a vaccine program (for free) over 15 months period in 2009-2010 in one city in north Jordan called Ajlun. This city has 3676 births per year (Statistics of the MOH 2007). The vaccination program will start from the 18th of May, 2009, and ending in August 2010. The way the vaccine will be given is 2 + 1 injections as recommended by the vaccination committee of the MOH.

NCT ID: NCT00861380 Completed - Clinical trials for Infections, Streptococcal

Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease

FinIP
Start date: May 4, 2009
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions. This study will also explore vaccine impact on occurrence of respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.

NCT ID: NCT00849069 Terminated - Clinical trials for Streptococcus Pneumoniae

Study to Assess the Safety of a New GSK Biologicals' GSK2231395A Candidate Vaccine

Start date: March 12, 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK2231395A candidate vaccine in adults and elderly adults with chronic obstructive pulmonary disease. Subjects will be vaccinated 3 times with an interval of respectively 2 and 10 months.

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: 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: NCT00814489 Completed - Clinical trials for Streptococcus Pneumoniae

Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults

Start date: January 8, 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third dose of the vaccine at Month 6. The protocol posting has been updated following a protocol amendment.