Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05452941
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2022-07-06
Brief Title:
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 4 Study Using a Test-Negative Design to Evaluate the Effectiveness of a 20-valent Pneumococcal Conjugate Vaccine Against Vaccine-type Radiologically-confirmed Community-acquired Pneumonia in Adults 65 Years of Age
Status:
RECRUITING
Status Verified Date:
2024-10
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 learn about how well the 20-valent pneumococcal conjugate vaccine 20vPnC works against radiologically-confirmed community-acquired pneumonia RADCAP due to the 7 new serotypes types of a bacteria called Streptococcus pneumoniae that cause pneumonia included in 20vPnC vaccine
This study is seeking participants who
are male or female 65 years of age
are hospitalized with physician suspicion of community acquired pneumonia CAP
have pneumonia confirmed with imaging like a chest x-ray
Participants will be asked to provide demographic and medical history information and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC Participants will actively take part in the study for about 1-2 days Information on participants illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review
This study is seeking participants who
are male or female 65 years of age
are hospitalized with physician suspicion of community acquired pneumonia CAP
have pneumonia confirmed with imaging like a chest x-ray
Participants will be asked to provide demographic and medical history information and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC Participants will actively take part in the study for about 1-2 days Information on participants illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review
Detailed Description:
This is an observational test-negative design study in which all study participants are adults 65 years of age hospitalized with RADCAP at one of the study sites The only protocol-specified study procedure is a non-invasive urine specimen collection for pneumococcal detection using BinaxNOW S pneumoniae and the serotype-specific urinary antigen detection UAD assays Cases and controls will be differentiated by the presence of vaccine serotypes that are identified by any method including Quellung reaction of pneumococcal isolates obtained from standard of care SOC cultures from blood or high-quality respiratory tract specimens or serotype specific UAD assays performed on urine specimens The serotype-specific UAD assays termed UAD-1 and UAD-2 detect the 13 serotypes in 13vPnC 1 3 4 5 6AC 6BD 7FA 9VA 14 18CA B F 19A 19F 23F UAD-1 and 11 additional serotypes 2 8 9N 10A39 11ADF 12F 15BC 17FA 20AB 22FA 33FA UAD-2 For the primary objective cases will be defined as participants hospitalized for RADCAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RADCAP of non-pneumococcal etiologies will serve as test-negative controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None