Pneumonia Vaccine Research Begins Large Scale - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), 23 September announced the start of Community Acquired Pneumonia Immunization Trial in Adults, a large-scale study of 13-valent vaccine in adults conducted to prevent the disease pneumococcal pneumonia - the leading cause of bacterial pneumonia in adults.
In Europe and the United States, pneumococcal pneumonia is an infection acquired bacterial pneumonia in the community, with an average mortality (death) in adults between 10 to 20 percent. That rate may exceed 50 percent in high-risk groups worldwide.
The results of this study is not intended or required in the registration document which is used for 13-valent vaccine in adults. Research carried out this proactively as part of a Phase 4 commitment, in agreement with the U.S. Food and Drug Administration (U.S. FDA).
Community Acquired Pneumonia Immunization Trial in Adults is a double-blind study with placebo control is expected to involve 85.000 participants aged 65 years and over. This research was conducted by the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht in the Netherlands. Participants in this study will receive either Wyeth's investigational pneumococcal conjugate vaccine or placebo 13-valent.
"We are very excited to conduct this major trial aimed at infectious diseases of pneumonia, which is important in adults," says Marc Bonten, MD, principal investigator of the study and Professor of Molecular Epidemiology of Infectious Diseases, Department of Medical Microbiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht.
"The primary goal of this study was to evaluate whether the vaccine is effective in preventing community acquired pneumonia caused by serotypes included in the vaccine. The study also will evaluate whether the vaccine is effective for preventing all-cause pneumonia and invasive pneumococcal disease (IPD). "
Preparations for the study 13-valent vaccine being evaluated in this trial in adults uses Wyeth conjugation technology, and based on PREVENAR vaccines (Pneumococcal Saccharide Conjugated Vaccine).
PREVENAR is indicated for active immunization in infants and children from ages 6 weeks through 9 years against invasive disease, pneumonia and otitis media caused by the bacteria Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F .
The study vaccine includes serotypes (1, 3, 5, 6A, 7F and 19A), in addition to the seven serotypes included in PREVENAR *.
In the world of vaccine 13-valent pneumococcal conjugate is currently in late-stage clinical trials research in both infants and adults.
"Pneumococcal pneumonia in adults represents a significant burden, both clinically and economically," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "This will be an important trial to evaluate our conjugate vaccine's potential to be medically necessary."
About Pneumonia and Pneumococcal Disease
Pneumonia is the leading cause of death and hospitalization, costing health care systems millions of dollars and an estimated 600,000 adult deaths worldwide each year.
Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae and a group of illnesses, including invasive infections, such as bacteremia / sepsis and meningitis, as well as pneumonia and upper respiratory tract infection.
Although all age groups can be affected, the highest rate of pneumococcal disease occur in children (under five) and old age. In addition, people who suffer from other chronic diseases (eg, diabetes, cardiovascular disease) and immune deficiencies are at increased risk.
Important Safety Information PREVENAR
In clinical studies (n = 18,168) in children, reported adverse event ever included injection site reactions, fever (≥ 38 ° C/100.4 º F), irritability, dizziness, lack of sleep, decreased appetite, vomiting, diarrhea and rash .
Risks associated with all vaccines, including PREVENAR *. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a kontaindikasi. PREVENAR does not provide 100% protection against vaccine serotypes or serotypes in non-vaccine.
Many pathogenic bacteria other than the pneumococcal serotypes included in the vaccine may contribute to the occurrence of infectious pneumonia, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
* PREVENAR is not indicated separately used in adults or in infants younger than 6 weeks.
In Europe and the United States, pneumococcal pneumonia is an infection acquired bacterial pneumonia in the community, with an average mortality (death) in adults between 10 to 20 percent. That rate may exceed 50 percent in high-risk groups worldwide.
The results of this study is not intended or required in the registration document which is used for 13-valent vaccine in adults. Research carried out this proactively as part of a Phase 4 commitment, in agreement with the U.S. Food and Drug Administration (U.S. FDA).
Community Acquired Pneumonia Immunization Trial in Adults is a double-blind study with placebo control is expected to involve 85.000 participants aged 65 years and over. This research was conducted by the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht in the Netherlands. Participants in this study will receive either Wyeth's investigational pneumococcal conjugate vaccine or placebo 13-valent.
"We are very excited to conduct this major trial aimed at infectious diseases of pneumonia, which is important in adults," says Marc Bonten, MD, principal investigator of the study and Professor of Molecular Epidemiology of Infectious Diseases, Department of Medical Microbiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht.
"The primary goal of this study was to evaluate whether the vaccine is effective in preventing community acquired pneumonia caused by serotypes included in the vaccine. The study also will evaluate whether the vaccine is effective for preventing all-cause pneumonia and invasive pneumococcal disease (IPD). "
Preparations for the study 13-valent vaccine being evaluated in this trial in adults uses Wyeth conjugation technology, and based on PREVENAR vaccines (Pneumococcal Saccharide Conjugated Vaccine).
PREVENAR is indicated for active immunization in infants and children from ages 6 weeks through 9 years against invasive disease, pneumonia and otitis media caused by the bacteria Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F .
The study vaccine includes serotypes (1, 3, 5, 6A, 7F and 19A), in addition to the seven serotypes included in PREVENAR *.
In the world of vaccine 13-valent pneumococcal conjugate is currently in late-stage clinical trials research in both infants and adults.
"Pneumococcal pneumonia in adults represents a significant burden, both clinically and economically," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "This will be an important trial to evaluate our conjugate vaccine's potential to be medically necessary."
About Pneumonia and Pneumococcal Disease
Pneumonia is the leading cause of death and hospitalization, costing health care systems millions of dollars and an estimated 600,000 adult deaths worldwide each year.
Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae and a group of illnesses, including invasive infections, such as bacteremia / sepsis and meningitis, as well as pneumonia and upper respiratory tract infection.
Although all age groups can be affected, the highest rate of pneumococcal disease occur in children (under five) and old age. In addition, people who suffer from other chronic diseases (eg, diabetes, cardiovascular disease) and immune deficiencies are at increased risk.
Important Safety Information PREVENAR
In clinical studies (n = 18,168) in children, reported adverse event ever included injection site reactions, fever (≥ 38 ° C/100.4 º F), irritability, dizziness, lack of sleep, decreased appetite, vomiting, diarrhea and rash .
Risks associated with all vaccines, including PREVENAR *. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a kontaindikasi. PREVENAR does not provide 100% protection against vaccine serotypes or serotypes in non-vaccine.
Many pathogenic bacteria other than the pneumococcal serotypes included in the vaccine may contribute to the occurrence of infectious pneumonia, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
* PREVENAR is not indicated separately used in adults or in infants younger than 6 weeks.
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