PG4 Multivalent Vaccine for Pneumococcal Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine for pneumococcal disease, an infection caused by bacteria that can lead to illnesses like pneumonia. The goal is to determine if the PG4 Multivalent Vaccine is as safe as the current vaccine and to ensure consistent performance across different batches. Participants will receive one shot of either the new or current vaccine, and blood samples will be collected to assess the body's response. The study seeks adults aged 18-49 who haven't received a pneumococcal vaccine since age 5. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new vaccine.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the PG4 multivalent vaccine is generally well-tolerated. Previous studies found that this new pneumococcal vaccine is as safe as existing vaccines, with no unexpected side effects reported. Participants did not experience unusual reactions.
The 20vPnC vaccine is already approved for preventing pneumococcal disease, indicating a proven safety record. Participants in trials for this vaccine usually experienced mild side effects, such as soreness at the injection site or a slight fever, which are common with many vaccines.
Both vaccines under study have shown promising safety results in earlier research, indicating they are considered safe enough for testing in large groups of people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the PG4 Multivalent Vaccine because it offers a broader range of protection against pneumococcal disease compared to existing vaccines. While standard vaccines like the 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) cover a limited number of pneumococcal strains, the PG4 vaccine is designed to target multiple strains with its multivalent approach. This could potentially enhance effectiveness and provide better protection against emerging strains, making it a promising option in the fight against pneumococcal infections.
What evidence suggests that this trial's vaccines could be effective for pneumococcal disease?
Research has shown that vaccines like the PG4, which protect against multiple strains of bacteria, are effective. In this trial, participants will receive either the PG4 Multivalent Vaccine or the 20 Valent Pneumococcal Conjugate Vaccine (20vPnC). Earlier vaccines for pneumococcal disease, which included different types of bacteria, successfully prevented infections. These vaccines help the body recognize and combat various bacteria that cause pneumococcal disease. The 20vPnC vaccine, currently in use, has also proven effective in preventing pneumococcal disease by targeting 20 different strains of bacteria, offering broad protection. Overall, both the PG4 and 20vPnC vaccines have strong scientific evidence supporting their effectiveness against pneumococcal disease.678910
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults in the United States who are generally healthy and able to receive a pneumococcal vaccine. People with certain health conditions or allergies that could interfere with vaccination may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one vaccine injection with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC
Follow-up
Participants are monitored for safety and effectiveness after vaccination, including local and systemic reactions, adverse events, and immunogenicity assessments
What Are the Treatments Tested in This Trial?
Interventions
- 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
- PG4 Multivalent Vaccine
Trial Overview
The study compares three different batches of a new multivalent pneumococcal vaccine (PG4) to each other and to an existing approved vaccine (20vPnC). Participants get one shot, assigned by chance, and their immune response is measured over about 6 months.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Multivalent Pneumococcal Vaccine
Multivalent Pneumococcal Vaccine
Multivalent Pneumococcal Vaccine
20 Valent Pneumococcal Conjugate Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
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
JVI Table of Contents Volume 100, Issue 7
This study provides convincing evidence for the effectiveness of a multivalent vaccine against highly pathogenic influenza A viruses. xml. VirologyResearch ...
2.
ptacts.uspto.gov
ptacts.uspto.gov/ptacts/public-informations/petitions/1502094/download-documents?artifactId=ev6y_jmtqOwH8fOSFk7YsInFkV29LvSqNdTdaCwtwH6FyFVNE9mJxhUUNITED STATES PATENT AND TRADEMARK OFFICE
While early multivalent pneumococcal vaccines comprising unconjugated, or “free,” polysaccharides from different serotypes were effective in immunizing ...
Department of Immunization, Vaccines and Biologicals (IVB)
One of the outcomes listed in the next paragraph can occur depending on the circumstances (e.g, nature and magnitude of the interest, timeframe and duration of ...
Immunogenic compositions for use in pneumococcal ...
An object of the present invention is to provide immunogenic compositions for protection against S. pneumoniae, in particular against S. pneumoniae ...
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ctv.veeva.com
ctv.veeva.com/study/study-to-learn-about-safety-tolerability-and-immune-response-of-a-catch-up-pneumococcal-vaccine-inStudy to Learn About Safety, Tolerability, and Immune ...
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight ...
10.
tipranks.com
tipranks.com/news/weekend-updates/pfizer-pfe-quietly-arms-pipeline-for-next-growth-wavePfizer (PFE) Quietly Arms Pipeline for Next Growth Wave
Pfizer has completed a Phase 2 trial of its next-generation multivalent pneumococcal conjugate vaccine, PG4, in toddlers, comparing it to its ...
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