Learning how the 20-valent pneumococcal vaccine works against pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of the 20-valent pneumococcal conjugate vaccine (20vPnC) in preventing radiologically-confirmed community-acquired pneumonia (CAP) caused by specific serotypes of Streptococcus pneumoniae. Participants aged 65 and older who are hospitalized with suspected CAP will provide demographic and medical history information, along with a urine sample for testing. The study will compare the incidence of pneumonia caused by vaccine serotypes in vaccinated individuals versus those who are unvaccinated. The primary objective is to identify cases of pneumonia linked to the additional serotypes included in the 20vPnC vaccine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female participants ≥65 years of age.
2. Hospitalized participant with physician clinical suspicion of CAP with the presence of ≥2 of the following 10 clinical signs or symptoms:

   * fever (oral temperature \>38.0°C/100.4°F or tympanic temperature \>38.5°C/101.2°F),
   * hypothermia (\<35.5°C/95.9°F measured by a healthcare provider)
   * 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).
3. Has a radiographic finding that is consistent with pneumonia (e.g., pleural effusion, increased pulmonary density due to infection, the presence of alveolar infiltrates \[multi-lobar, lobar, or segmental\] containing air bronchograms).
4. Capable of giving signed informed consent

Exclusion Criteria:

1. Any participant who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at the study site, another transferring hospital, or a combination of these).
2. Received any pneumococcal vaccine ≤30 days prior to enrollment.
3. Unable to provide urine specimen (e.g. anuric).
4. Previous enrollment in the study within the past 30 days.

Where it's running

• El Centro Regional Medical Center
  El Centro, California, United States Recruiting
• Kaiser Permanente Fontana Medical Center
  Fontana, California, United States Recruiting
• Kaiser Permanente West Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Kaiser Permanente Vaccine Study Center
  Oakland, California, United States Recruiting
• Kaiser Permanente Oakland Medical Center
  Oakland, California, United States Recruiting
• Kaiser Permanente Ontario Medical Center
  Ontario, California, United States Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.