A Study to Learn About a Type of Pneumococcal Vaccine With a New Ingredient (PF-07872411) Intended to Enhance the Effects of the Vaccine Which is Given to Adults

Last updated: July 26, 2024
Sponsor: Pfizer
Overall Status: Completed

Phase

1

Condition

Pneumococcal Disease

Treatment

Low dose of multivalent pneumococcal conjugate vaccine control

Standard dose multivalent pneumococcal conjugate vaccine control

Low dose multivalent pneumococcal conjugate vaccine formulation B

Clinical Study ID

NCT05831124
C4941001
  • Ages 50-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infections and sinusitis.

Meningitis is an infection in which the tissue around the brain and spine is swollen.

Sepsis is a very serious infection in your blood caused by a germ (a bacteria). Sinusitis is when your sinuses (the air-filled spaces inside your nose and head), are infected.

This study is seeking for healthy participants who:

  • are above 50 years of age and less than 64 years of age.

  • have not taken any vaccine for pneumococcal diseases before.

  • have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine.

All participants will receive a single study vaccine shot in the upper arm muscle at the study clinic. The study will compare the experiences of people receiving the vaccine with a new ingredient in the vaccine to those without the new ingredient. This will be done by comparing 2 different dose levels of the new ingredient. It will also be compared against people who receive the vaccine without the new ingredient and at different dose levels. This will help the study team establish if the vaccine with a new ingredient is safe and effective.

Participants will take part in this study for about 12 months. During this time participants will have up to 6 clinic 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 these visits.

Some participants will need to have blood taken for laboratory tests before they can be judged to be eligible to be included in the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants ≥50 and ≤64 years of age at the time of consent.

  • Adults determined by clinical assessment, including medical history and clinicaljudgment, to be eligible for the study, including those with preexisting stabledisease, defined as disease not requiring significant change in therapy orhospitalization for worsening disease, within 6 months before receipt of studyintervention.

  • Female participants of childbearing potential or male participants able to fatherchildren and who are willing to use acceptable methods of contraception for at least 28 days after the last dose of study intervention; or female participants not ofchildbearing potential; or male participants not able to father children.

Exclusion

Exclusion Criteria:

  • History of a severe adverse reaction associated with a vaccine and/or severeallergic reaction (eg, anaphylaxis) to any component in pneumococcal conjugatevaccines and any other diphtheria toxoid-containing vaccine.

  • Serious chronic disorder, including history of metastatic malignancy, severe COPDrequiring supplemental oxygen, end-stage renal disease with or without dialysis,cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder,that in the investigator's opinion, would make the participant inappropriate forentry into the study.

  • History of microbiologically proven invasive disease caused by S pneumoniae.

  • Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illnesswithin 48 hours before study intervention administration.

  • Pregnant female participants or breastfeeding female participants (known orsuspected).

  • Previous vaccination with any licensed or investigational pneumococcal vaccine, orplanned receipt of any licensed or investigational pneumococcal vaccine throughstudy participation.

  • Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any livevaccine within 28 days before administration of study intervention.

  • Receipt of an adjuvanted vaccine containing QS-21 (or similar saponin adjuvant),MPL, or MF59 within 1 year before administration of study intervention

Study Design

Total Participants: 90
Treatment Group(s): 4
Primary Treatment: Low dose of multivalent pneumococcal conjugate vaccine control
Phase: 1
Study Start date:
April 19, 2023
Estimated Completion Date:
June 26, 2024

Connect with a study center

  • Indago Research & Health Center, Inc

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Research Centers of America

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Research Centers of America ( Hollywood )

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Centennial Medical Group

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Centennial Medical Group

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas 78229
    United States

    Site Not Available

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