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

A PHASE 1, RANDOMIZED, DOUBLE-BLIND STUDY OF THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE WITH AN ADJUVANT ADMINISTERED IN ADULTS 50 THROUGH 64 YEARS OF AGE

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Other: Low dose multivalent pneumococcal conjugate vaccine formulation A; Other: Low dose multivalent pneumococcal conjugate vaccine formulation B; Biological: Low dose of multivalent pneumococcal conjugate vaccine control; Biological: Standard dose multivalent pneumococcal conjugate vaccine control

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Hollywood, Florida, United States, 33024
      • Research Centers of America ( Hollywood )
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Centennial Medical Group
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, LLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 clinical judgment, to be eligible for the study, including those with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease, within 6 months before receipt of study intervention.
• Female participants of childbearing potential or male participants able to father children 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 of childbearing potential; or male participants not able to father children.

Exclusion Criteria:

• History of a severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine.
• Serious chronic disorder, including history of metastatic malignancy, severe COPD requiring 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 for entry 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 illness within 48 hours before study intervention administration.
• Pregnant female participants or breastfeeding female participants (known or suspected).
• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
• Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose multivalent pneumococcal conjugate vaccine formulation A; Stage 1 - Participants will be randomized to receive a single injection.	Other: Low dose multivalent pneumococcal conjugate vaccine formulation A; Biological
Experimental: Low dose multivalent pneumococcal conjugate vaccine formulation B; Stage 2 - Participants will be randomized to receive a single injection.	Other: Low dose multivalent pneumococcal conjugate vaccine formulation B; Biological
Active Comparator: Low dose of multivalent pneumococcal conjugate vaccine control; Primary control - Stages 1 and 2 - Participants will be randomized to receive a single injection.	Biological: Low dose of multivalent pneumococcal conjugate vaccine control; low dose multivalent pneumococcal conjugate vaccine; Other Names: Primary control
Active Comparator: Standard dose multivalent pneumococcal conjugate vaccine control; Control - Stages 1 and 2 - Participants will be randomized to receive a single injection.	Biological: Standard dose multivalent pneumococcal conjugate vaccine control; multivalent pneumococcal conjugate vaccine; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting local reactions within 7 days after vaccination	Local reactions (redness, swelling, pain at the injection site) after vaccination.	7 days
Percentage of participants reporting systemic events within 7 days after vaccination	Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain, and joint pain) after vaccination.	7 days
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination	Adverse Events occurring within 1 month after vaccination.	1 month
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination	SAEs occurring within 6 months after vaccination.	6 months
Percentage of participants reporting Serious Adverse Events (SAEs) withing 12 months after vaccination	SAEs occurring within 12 months after vaccination.	12 months
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) within 6 months after vaccination	NDCMCs occurring within 6 months after vaccination.	6 months
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) withing 12 months after vaccination	NDCMCs occurring within 12 months after vaccination.	12 months
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination	MAAEs occurring within 6 months after vaccination.	6 months
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination	MAAEs occurring within 12 months after vaccination.	12 months
Stage 1 and Stage 2 Only - Percentage of participants with abnormal hematology and chemistry laboratory values 2 weeks after vaccination	Abnormal hematology and chemistry laboratory values occurring 2 weeks after vaccination.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal opsonophagocytic activity (OPA) titers	OPA geometric mean titers (GMTs) 1 month after vaccination	1 month

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: C4941001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No