Trial Outcomes & Findings for PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older (NCT NCT04613375)

NCT ID: NCT04613375

Last Updated: 2025-06-11

Results Overview

Cases were participants with CAP with a valid urinary antigen detection (UAD) result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure.

Recruitment status

COMPLETED

Target enrollment

1821 participants

Primary outcome timeframe

Approximately 30 months

Results posted on

2025-06-11

Participant Flow

Participants were evaluated for effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13) \[received previously at least 30 days before hospitalization\] in preventing vaccine-type (VT) pneumococcal hospitalized community acquired pneumonia (CAP) among adults aged greater than or equal to (\>=) 60 years in Madrid in this observational study.

A total of 1821 participants were enrolled in this study and 51 participants did not meet inclusion/exclusion of the study. In this study, a) pandemic period included data from 12 March 2021 to 31 July 2022 when last relevant coronavirus disease 2019 (COVID-19) wave in target population (aged \>=60 years) ended in Madrid; b) post-pandemic period included data from 01 August 2022 to 13 September 2023.

Participant milestones

Participant milestones
Measure	All Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Overall Study STARTED	1821
Overall Study Per-protocol Population	1770
Overall Study CAP Population	1680
Overall Study CAP Urinary Antigen Detection (UAD) Population	1512
Overall Study COMPLETED	1620
Overall Study NOT COMPLETED	201

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Overall Study Death	198
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=1770 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Age, Continuous	78.08 Years STANDARD_DEVIATION 9.14 • n=1770 Participants
Sex: Female, Male Female	761 Participants n=1770 Participants
Sex: Female, Male Male	1009 Participants n=1770 Participants

PRIMARY outcome

Timeframe: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

Cases were participants with CAP with a valid urinary antigen detection (UAD) result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=1512 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall Cases	105 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall Controls	1407 Participants

SECONDARY outcome

Timeframe: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number Analyzed" signifies participants who were evaluable for each category.

Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=1501 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall Received PCV13 in <2 years or not received PCV13 · Cases	66 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall Received PCV13 in <2 years or not received PCV13 · Controls	910 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall Received PCV13 in 2-<5 years or not received PCV13 · Cases	89 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall Received PCV13 in 2-<5 years or not received PCV13 · Controls	1116 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall Received PCV13 in >=5 years or not received PCV13 · Cases	66 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall Received PCV13 in >=5 years or not received PCV13 · Controls	833 Participants

SECONDARY outcome

Timeframe: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

Percentage of CAP participants in whom streptococcus pneumoniae was identified for PCV13 and 20-valent pneumococcal conjugate vaccine (PCV20) serotypes is reported.

Outcome measures

Outcome measures
Measure	All Participants n=1512 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified PCV13 Serotypes	6.9 Percentage of CAP participants Interval 5.7 to 8.3
Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified PCV20 Serotypes	13.2 Percentage of CAP participants Interval 11.5 to 15.0

SECONDARY outcome

Timeframe: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" signifies participants who had a valid saliva specimen test result.

Respiratory pneumococcal carriage was determined by testing saliva specimens using both conventional culture and the sensitive molecular method of PCR for the detection of two target genes (lytA and piaB).

Outcome measures

Outcome measures
Measure	All Participants n=1314 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR)	11.6 Percentage of CAP participants Interval 9.9 to 13.4

SECONDARY outcome

Timeframe: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

At-risk medical conditions included: alcoholism, asthma, celiac disease, chronic liver disease with hepatic failure, chronic liver disease without hepatic failure, chronic neurologic diseases, chronic obstructive pulmonary disease, coagulation factor replacement therapy, cochlear implant, congestive heart failure, coronary artery disease, cerebrospinal fluid leak, diabetes treated with medication, down syndrome, living in a nursing home, living in a long-term care facility, occupational risk with exposure to metal fumes, other chronic heart disease, other chronic lung disease, other pneumococcal disease risk factors, previous invasive pneumococcal disease, tobacco smoking (tobacco/e-cigarettes).

Outcome measures

Outcome measures
Measure	All Participants n=1512 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Percentage of CAP Participants With Underlying At-risk Medical Conditions	55.2 Percentage of CAP participants

SECONDARY outcome

Timeframe: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

High-risk medical conditions included: asplenia, cancer/malignancy (hematologic), cancer/malignancy (solid tumor), chronic kidney disease, human immunodeficiency virus (HIV) - acquired immunodeficiency syndrome (AIDS), HIV - No AIDS, immunodeficiency, immunosuppressant drug therapy, multiple myeloma, organ transplantation.

Outcome measures

Outcome measures
Measure	All Participants n=1512 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Percentage of CAP Participants With Underlying at High-Risk Medical Conditions	35.6 Percentage of CAP participants

SECONDARY outcome

Timeframe: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" = participants in CAP UAD population from whom valid SP isolates were obtained; "Number of SP isolates analyzed" = number of SP isolates with antimicrobial susceptibility tests performed. Only isolates with antimicrobial susceptibility tests performed were included in analysis.

Percentage of SP isolates with antibiotic resistance to penicillin, amoxicillin, cefotaxime, erythromycin, tetracycline, levofloxacin were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=33 SP isolates Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance Penicillin	9.1 Percentage of SP isolates
Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance Amoxicillin	9.1 Percentage of SP isolates
Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance Cefotaxime	3.0 Percentage of SP isolates
Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance Erythromycin	12.1 Percentage of SP isolates
Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance Tetracycline	12.1 Percentage of SP isolates
Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance Levofloxacin	3.0 Percentage of SP isolates

POST_HOC outcome

Timeframe: Approximately 13.5 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" signifies participants in CAP UAD population for post-pandemic period.

Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=1241 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Number of Participants Categorized as Cases and Controls to Determine VE of PCV13 Against Hospitalized VT CAP: Post-Pandemic Period Cases	89 Participants
Number of Participants Categorized as Cases and Controls to Determine VE of PCV13 Against Hospitalized VT CAP: Post-Pandemic Period Controls	1152 Participants

POST_HOC outcome

Timeframe: Approximately 13.5 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" signifies participants in CAP UAD population for post-pandemic period and "Number Analyzed" signifies participants who were evaluable for each category.

Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure.

Outcome measures

Outcome measures
Measure	All Participants n=1241 Participants Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study.
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Post-pandemic Period Received PCV13 in <2 years or not received PCV13 · Cases	55 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Post-pandemic Period Received PCV13 in <2 years or not received PCV13 · Controls	723 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Post-pandemic Period Received PCV13 in 2-<5 years or not received PCV13 · Cases	79 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Post-pandemic Period Received PCV13 in 2-<5 years or not received PCV13 · Controls	920 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Post-pandemic Period Received PCV13 in >=5 years or not received PCV13 · Cases	57 Participants
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Post-pandemic Period Received PCV13 in >=5 years or not received PCV13 · Controls	667 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 198 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer Clinical Trials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER