Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133549
Status:
COMPLETED
Last Update Posted:
2014-10-17
First Post:
2005-08-19
Brief Title:
9-valent CRM 197 Pneumococcal
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of a 9-valent CRM 197- Conjugated Pneumococcal Polysaccharide Vaccine in Elderly Adults
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults Study participants will include 180 adults 65 years of age or greater Participants will be randomly assigned to 1 of 3 possible groups Subjects will maintain a study diary to record side effects and oral temperatures for 7 days following each vaccination Blood samples will be collected before and 1 month following each dose of vaccine or placebo Participants will be involved in study related procedures for up to 268 days
Detailed Description:
Elderly individuals are at an increased risk for serious pneumococcal infection The efficacy of the licensed pneumococcal vaccine is also lower in this at risk population The precise immunologic reason for the increased susceptibility and decreased efficacy with advancing age is unknown Understanding and improving the response to pneumococcal vaccine in persons over the age of 65 is an important step in preventing this serious illness The proposed study will evaluate the relative safety and immunogenicity of 9-valent CRM 197 protein-conjugated pneumococcal polysaccharide CRM-PS compared to the currently licensed 23-polysaccharide PS vaccines in elderly adults In addition the response to revaccination following conjugate vaccine will also be evaluated Outcome measurements will include adverse effects standard ELISA measurements of serotype specific antibody as well as antibody response to carrier protein effects on functional antibody status and on nasal carriage of S pneumoniae The study will be conducted in 180 adults who are 65 years of age and older and who have not received pneumococcal vaccine within the last 5 years Patients will be assigned to 1 of 3 groups at random in a double blind manner One dose of vaccine and 1 dose of placebo or 2 doses of 9-valent CRM-PS vaccine will be administered at an interval of 4 months and compared to a single dose of PS vaccine and 1 dose of placebo Subjects will be evaluated for local and system side effects using a 7-day diary card and clinical and telephone follow-up Serologic evaluation will be done before and 1 month following each vaccination or placebo Subjects who received CRM-PS will receive a dose of PS vaccine 8 months after the first dose of vaccine and potential priming by previous conjugate vaccine will be assessed by measuring the quality and quantity of the antibody response to revaccination Participants will be involved in study related procedures for up to 268 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None