4670 Participants NeededMy employer runs this trial

PG4 Multivalent Vaccine for Pneumococcal Disease

Recruiting at 36 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

PC

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

I am between 18 and 49 years old.
I have not received a pneumococcal vaccine since I was 5 years old.

Exclusion Criteria

Known or suspected immunodeficiency
Serious chronic medical disorders
I am currently pregnant or breastfeeding.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one vaccine injection with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, including local and systemic reactions, adverse events, and immunogenicity assessments

6 months
Multiple visits (in-person and virtual)

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

Group I: PG4 Vaccine Lot 3Experimental Treatment1 Intervention
Group II: PG4 Vaccine Lot 2Experimental Treatment1 Intervention
Group III: PG4 Vaccine Lot 1Experimental Treatment1 Intervention
Group IV: 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)Active Control1 Intervention

Find a Clinic Near You

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 profile image

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 ...

UNITED 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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