RecruitingPhase 1NCT07086677

A Study to Learn About How a New Pneumococcal Vaccine Works in Adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS


Sponsor

Pfizer

Enrollment

372 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: * an experimental PG4 vaccine * a PG4 vaccine comparator * a standard 20vPnC vaccine comparator * placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.


Eligibility

Min Age: 65 YearsMax Age: 84 Years

Inclusion Criteria2

  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Participants either with no history of ever receiving a pneumococcal vaccine or who have received a pneumococcal vaccine more than 5 years prior to vaccination in this study

Exclusion Criteria1

  • • Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.

Interventions

BIOLOGICALPG4 vaccine in Buffer 1 with low dose PA-001

Multivalent pneumococcal conjugate vaccine

BIOLOGICALPG4 in Buffer 1 with low dose PA-002

Multivalent pneumococcal conjugate vaccine

BIOLOGICALPG4 in Buffer 1 with high dose PA-001

Multivalent pneumococcal conjugate vaccine

BIOLOGICALPG4 vaccine in Buffer 1 with high dose PA-002

Multivalent pneumococcal conjugate vaccine

BIOLOGICALPG4 vaccine in Buffer 2

Multivalent pneumococcal conjugate vaccine

BIOLOGICAL20-valent pneumococcal conjugate vaccine

(20vPnC)

BIOLOGICALSaline injection

Placebo


Locations(5)

Orange County Research Center

Lake Forest, California, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Johnson County Clinical Trials

Lenexa, Kansas, United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07086677


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