Pneumococcal Vaccine for Pneumonia

Recruiting at 102 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Pfizer

Disqualifiers: Recent pneumococcal vaccine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

12500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the 20-valent pneumococcal conjugate vaccine (20vPnC) in preventing pneumonia caused by specific strains of Streptococcus pneumoniae. The focus is to determine if this vaccine prevents pneumonia confirmed by imaging tests like chest x-rays. Suitable participants are those aged 65 or older, hospitalized with pneumonia symptoms such as fever or shortness of breath, and have their condition confirmed through imaging. Participants will provide basic health information and a urine sample. Researchers will compare those who have received the vaccine to those who have not. The trial will collect information during the hospital stay and follow up on the illness for up to 30 days. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new preventive treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for the 20-valent pneumococcal conjugate vaccine (20vPnC)?

Research has shown that the 20-valent pneumococcal conjugate vaccine (20vPnC), also known as Prevnar 20®, is generally well-tolerated. Most side effects are mild and temporary, including pain at the injection site, muscle pain, tiredness, and headaches, typically lasting just a day or two.

In rare cases, some individuals might experience a serious allergic reaction, such as anaphylaxis, which requires immediate medical attention. However, most side effects are not serious and mainly involve minor reactions like pain and redness at the injection site or a mild fever.

Overall, evidence suggests that 20vPnC is safe for most people, with the majority experiencing only mild and short-lived side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the 20-valent pneumococcal conjugate vaccine (20vPnC) because it targets 20 different strains of the bacteria that can cause pneumonia, including seven additional serotypes beyond the ones covered by the existing 13-valent vaccine. This broader coverage means it has the potential to protect against more types of pneumococcal disease, which is a significant improvement over current vaccines. By expanding the range of protection, 20vPnC could reduce hospitalizations due to pneumococcal pneumonia more effectively than the current standard, potentially saving more lives and decreasing healthcare costs.

What evidence suggests that the 20-valent pneumococcal conjugate vaccine is effective against community-acquired pneumonia?

Studies have shown that the 20-valent pneumococcal conjugate vaccine (20vPnC), which participants in this trial may receive, effectively combats infections caused by Streptococcus pneumoniae, the bacteria often responsible for pneumonia. Research indicates that vaccines similar to 20vPnC, such as PCV13 and PPSV23, have successfully reduced the risk of pneumonia in adults. The 20vPnC vaccine protects against seven more types of these bacteria compared to earlier versions, potentially offering broader protection. Initial findings suggest that these additional types could enhance the vaccine's ability to prevent pneumonia confirmed by x-ray. The CDC's assessment supports the vaccine's positive effects in reducing disease cases. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

Male or female participants ≥65 years of age.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

1 visit (in-person)

Observation

Participants provide demographic and medical history information, and a urine sample for pneumococcal detection

1-2 days

1 visit (in-person)

Follow-up

Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review

30 days

Long-term Follow-up

Vaccine effectiveness and clinical characteristics of disease and hospitalization are monitored over a long-term period

55 months

What Are the Treatments Tested in This Trial?

Interventions

• 20-valent pneumococcal conjugate vaccine (20vPnC)

How Is the Trial Designed?

Group I: Control Experimental Treatment 1 Intervention

All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RAD+CAP of non-pneumococcal etiologies will serve as test-negative controls.

Group II: Case Experimental Treatment 1 Intervention

Cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified.

20-valent pneumococcal conjugate vaccine (20vPnC) is already approved in United States, European Union for the following indications:

Approved in United States as Prevnar 20 for:

• Invasive pneumococcal disease in infants and children

Approved in European Union as Prevnar 20 for:

• Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05452941

NCT05452941 | A Study to Learn About How 20-Valent ... The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10222197/

Systematic Review and Meta-Analysis of the Efficacy and ... In conclusion, our review showed that PCV13 and PPSV23 are both effective against VT-IPD and VT-pneumococcal pneumonia in adults. These data ...

3. prevnar20adult.pfizerpro.com prevnar20adult.pfizerpro.com/clinical-studies/capita

CAPiTa Clinical Study See risks & benefits. Learn more about the study design of PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) in pneumococcal vaccine-naïve adults.

4. cdc.gov cdc.gov/acip/grade/pneumo-PCV20-age-based.html

GRADE: 20-valent pneumococcal conjugate vaccine ... Beneficial and harmful outcomes for the GRADE assessment were selected by the ACIP Pneumococcal Vaccines Work Group calls and via an email survey in which Work ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06782282

A Study to Learn About How Well the Prevnar 20 Vaccine ... The purpose of this study is to learn about how well the Prevnar 20 vaccine (PCV20) stops invasive pneumococcal disease.

6. adult.prevnar20.com adult.prevnar20.com/safetyandsideeffects

Safety & Side Effects What are the possible side effects of Prevnar 20®? · Pain at the injection site · Muscle pain · Fatigue · Headache · Joint pain.

7. mayoclinic.org mayoclinic.org/drugs-supplements/pneumococcal-20-valent-conjugate-vaccine-intramuscular-route/description/drg-20516728

Pneumococcal 20-valent conjugate vaccine (intramuscular ... This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention.

8. cdc.gov cdc.gov/vaccine-safety/vaccines/pneumococcal.html

Pneumococcal Vaccine Safety The most common side effects reported after pneumococcal vaccination are mild and last for 1 or 2 days. These include: Feeling drowsy.

9. prevnar20.com prevnar20.com/

PREVNAR 20® (Pneumococcal 20-Valent Conjugate Vaccine ... In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973709/

Post‑licensure Safety Surveillance of 20‑Valent ... Most reports (94%) were non-serious and comprised self-limiting local and systemic reactions such as injection-site pain, erythema, fever, and ...