PG4 Multivalent Vaccine for Pneumococcal Disease

Not yet recruiting at 24 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?

The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine.

This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines.

The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC.

Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC.

Each participant will take part in the study for approximately 6 months.

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.
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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