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Pneumococcal Disease clinical trials

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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: NCT01767402 Completed - Clinical trials for Pneumococcal Disease

Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults

Start date: October 2003
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy elderly population aged 18-45 years of age.

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: NCT01564771 Completed - Clinical trials for Pneumococcal Disease

Serotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.

B1851065
Start date: January 2011
Phase:
Study type: Observational

Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates collected each year are limited and depict a certain proportion of patients who have easy access to tertiary care or have underlying medical reasons which necessitate inpatient care. It is also probable that the real burden of pneumococcal disease is not well estimated especially among adults. New additions in the laboratory setting such as the pneumococcal urine antigen assay (Binax NOW®) and the Urinary Antigen Diagnostic Assay (Luminex) for the detection of 13 serotype specific polysaccharides in human urine developed by Pfizer might be helpful in identifying more pneumococcal infections compared to the previous years. This NIS is based on the unmet scientific need to describe the serotype distribution and the resistance profile of isolates from X-Ray confirmed CAP in the present circumstances.

NCT ID: NCT01432158 Completed - Clinical trials for Pneumococcal Disease

Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines

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

This is an open-label phase III clinical trial. The purpose of this trial is to investigate in detail the kinetics of the immune response to Prevenar-13, a pneumococcal conjugate vaccine, compared to Pneumovax-II, a pneumococcal plain polysaccharide vaccine. With their consent, healthy adults (n=2 in each group) aged over 18 years who have not received any pneumococcal vaccine in the past will receive either vaccine at their first visit. Blood will be taken before vaccination and at day 0,1,2,4,6,8,10,12,14,16,18,20,23,26,30,35 as well as 2,6 and 12 months following vaccination. With specific consent, a small volume of blood will be used to store DNA and RNA for analysis of the genetic associations with immune responses and adverse reactions to vaccines as well as the RNA expression following a vaccination. Serum or plasma will be used to assess antibody level and available whole blood will be used for B cell assays and to examine immunoglobulin gene usage in B cells.

NCT ID: NCT01396434 Completed - Clinical trials for Pneumococcal Disease

Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

Start date: December 2011
Phase: Phase 4
Study type: Observational

Prevenar 13 is safe for administration to Filipinos.

NCT ID: NCT01298544 Completed - Clinical trials for Pneumococcal Disease

A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers

Start date: November 2010
Phase: Phase 4
Study type: Interventional

In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.

NCT ID: NCT01128426 Completed - Clinical trials for Pneumococcal Disease

Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

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

The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.

NCT ID: NCT01111214 Completed - Clinical trials for Pneumococcal Disease

Child Pneumococcal Serotype Epidemiology In Greece

Start date: November 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. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program. The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.