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Clinical Trials in the USA / NCT07086677
Active, not recruiting Phase 1

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

NCT07086677 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 1
Started
2025-07-22
Last updated
2026-06-22

Condition(s) studied

Streptococcus Pneumoniae

Investigational drug(s) / intervention(s)

PG4 vaccine in Buffer 1 with low dose PA-001PG4 in Buffer 1 with low dose PA-002PG4 in Buffer 1 with high dose PA-001PG4 vaccine in Buffer 1 with high dose PA-002PG4 vaccine in Buffer 220-valent pneumococcal conjugate vaccine →Saline injection

PG4 vaccine in Buffer 1 with low dose PA-001: Multivalent pneumococcal conjugate vaccine

PG4 in Buffer 1 with low dose PA-002: Multivalent pneumococcal conjugate vaccine

PG4 in Buffer 1 with high dose PA-001: Multivalent pneumococcal conjugate vaccine

PG4 vaccine in Buffer 1 with high dose PA-002: Multivalent pneumococcal conjugate vaccine

PG4 vaccine in Buffer 2: Multivalent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine: (20vPnC)

Saline injection: Placebo

Study 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

Sex
ALL
Min age
65 Years
Max age
84 Years
Healthy volunteers
Accepted
Key Inclusion Criteria: * 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 Key Exclusion Criteria: • Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.

Primary outcome measure(s)

  • Percentage of participants reporting prespecified local reactions after each dose. — Within 7 days after each study intervention.
    Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
  • Percentage of participants reporting prespecified systemic reactions after each dose. — Within 7 days after each study intervention.
    Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
  • Percentage of participants reporting adverse events. — From signing of the ICD to 1 month after last study intervention.
    Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
  • Percentage of participants reporting serious adverse events. — From signing of the ICD to 6 months after the last study intervention.
    Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.
  • Percentage of participants reporting serious adverse events. — From signing of the ICD to 12 months after the last study intervention.
    Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.
  • Percentage of participants with abnormal hematology and chemistry laboratory values. — Within 2 weeks after each study intervention.
    Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.

Trial sites (20)

FacilityCityRegionStatus
Orange County Research Center Lake Forest California
Peninsula Research Associates Rolling Hills Estates California
Finlay Medical Research Greenacres City Florida
Indago Research & Health Center, Inc. Miami Lakes Florida
Johnson County Clinical Trials Lenexa Kansas
Bio-Kinetic Clinical Applications, LLC dba QPS-MO Springfield Missouri
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center Springfield Missouri
Bio-Kinetic Clinical Applications, LLC dba QPS-MO Springfield Missouri
Velocity Clinical Research, Omaha Omaha Nebraska
Upstate Global Health Institute East Syracuse New York
NYU Langone Health Vaccine Center New York New York
Duke Vaccine and Trials Unit Durham North Carolina
CTI Clinical Research Center Cincinnati Ohio
Headlands Horizons, LLC dba Headlands Research-Brownsville Brownsville Texas
Valley Regional Medical Center Brownsville Texas
LabCorp Houston Texas
IMA Clinical Research San Antonio San Antonio Texas
Dynamed Clinical Research, LP d/b/a DM Clinical Research Tomball Texas
J. Lewis Research, Inc. / Foothill Family Clinic Salt Lake City Utah
J. Lewis Research, Inc. / Foothill Family Clinic South Salt Lake City Utah

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07086677 on ClinicalTrials.gov ↗ ← All trials in the USA