A Test-Negative Case-Control Study to Evaluate the Effectiveness of V116, Capvaxive (Tm) Against Pneumococcal Pneumonia in Older Adults

Study on Vaccine Effectiveness in Preventing Lung Infections in Older Adults

S
Samir Gupta, MD

Primary Investigator

Enrolling By Invitation
65 years or above
All
Phase N/A
25 participants needed
4 Locations

Brief description of study

The purpose of this study is to assess the effectiveness of CAPVAXIVE in preventing hospitalized, confirmed CAP (invasive and non-invasive) caused by S pneumoniae serotypes contained in CAPVAXIVE and/or cross-reactive serotypes 6C and 15B among participants who received no other pneumococcal vaccines than CAPVAXIVE in the previous 5 years.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Suspected CAP patients in adults ≥65 years of age who present to participating hospitals will be considered for enrollment into the study. Patients with confirmed CAP by clinical signs and symptoms and radiography will be the source population for case and control identification. A diagnosis of CAP will be made based on examination of radiologic imaging including chest x-ray, CT scan or MRI, and clinical judgment of attending physician.

Detailed description of study

This multi-country, observational study using both primary and secondary data collection with a test-negative case-control design will be conducted in hospitals in patients hospitalized for CAP. Hospitalization is defined as either an “in-hospital admission” or “observational stay” in the hospital. Patients presenting with suspected CAP to participating hospital sites will be considered for enrollment into the study. Eligible patients must satisfy all inclusion and exclusion criteria.

The TND is a robust observational study design for evaluating effectiveness of vaccines against infectious respiratory diseases and has been used to evaluate the effectiveness of pneumococcal vaccines against pneumococcal pneumonia.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Community-acquired Pneumonia (CAP)
  • Age: 65 years or above
  • Gender: All

Inclusion Criteria
1. Patient (or legally acceptable representative) has provided documented informed
consent for the study
2. Patient is:
 an individual of any sex or gender,
 ≥65 years of age in the US or age is in accordance with country-specific age-
based recommendations for CAPVAXIVE in adults
3. Patient evaluated at the hospital site with clinical suspicion of CAP and ≥2 of the
following clinical signs or symptoms (new or worsening):
 fever (≥38.0°C/100.4°F),
 hypothermia (temperature  chills or rigors,
 pleuritic chest pain,
 new or worsening cough,
 sputum production,
 dyspnea (shortness of breath),
 tachypnea (respiratory rate >20/min),
 malaise, or
 abnormal auscultatory findings suggestive of pneumonia (rales or evidence of
pulmonary consolidation including dullness on percussion, bronchial breath
sounds, or egophony).
4. Radiographic imaging performed and findings consistent with CAP

Exclusion Criteria
1. Transfer from inpatient status (eg other hospitals, skilled nursing care, or acute
rehabilitation)
Note: Escalation of care from non-admitted status in urgent care or emergency
department (ED) in another facility is not exclusionary
Note: Patients referred from assisted living care/centers is not exclusionary
2. Suspected aspiration pneumonia, suspected hospital-acquired bacterial pneumonia (if
a patient develops signs or symptoms 48 hours after being hospitalized), or suspected
ventilator-associated bacterial pneumonia
3. Patients hospitalized for pneumonia or respiratory infection and discharged within the
last 30 days
4. Patients with known bronchial obstruction or a history of post-obstructive pneumonia
Note: This criterion does not exclude patients who have chronic obstructive
pulmonary disease [COPD]
5. Patients with primary or metastatic lung cancer that is progressing or has required
active treatment within the 3 years prior to signing the informed consent’
6. Patients with cystic fibrosis, known or suspected Pneumocystis jirovecii pneumonia,
or known or suspected active tuberculosis
7. Patients who are not able or unwilling to provide a urine sample (eg, anuric)
All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee
to ensure that the patient qualifies for the study.

The purpose of this study is to investigate the effectiveness of an investigational vaccine in preventing pneumonia caused by specific bacteria in older adults. Pneumonia is a lung infection that can make it hard to breathe and may require hospitalization. This study focuses on older adults who have not received other pneumococcal vaccines in the past five years and are suspected of having pneumonia.

Participants in this study will be observed at hospitals where they are treated for pneumonia. The study will use both new and existing data to understand how well the vaccine works. Participants will be evaluated based on their symptoms and undergo imaging tests like x-rays to confirm pneumonia.

  • Who can participate: Adults aged 65 years or older who are suspected of having pneumonia and meet specific clinical criteria can participate. They must not have received other pneumococcal vaccines in the past five years.
  • Study details: Participants will be observed in hospitals if they have signs of pneumonia and will undergo tests to confirm the condition. The study does not involve any changes to their usual treatment.
Updated on 07 Jul 2026. Study ID: ECRO-MERCK-CAPVAXIVE, 30813
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only