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

NCT05831124 | Completed Phase 1 FDA Drug

• 1 other identifier: C4941001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• Pneumococcal opsonophagocytic activity (OPA) titers

  1 month

Study Arms (4)

Low dose multivalent pneumococcal conjugate vaccine formulation A

EXPERIMENTAL

Stage 1 - Participants will be randomized to receive a single injection.

Other: Low dose multivalent pneumococcal conjugate vaccine formulation A

Low dose multivalent pneumococcal conjugate vaccine formulation B

EXPERIMENTAL

Stage 2 - Participants will be randomized to receive a single injection.

Other: Low dose multivalent pneumococcal conjugate vaccine formulation B

Low dose of multivalent pneumococcal conjugate vaccine control

ACTIVE COMPARATOR

Primary control - Stages 1 and 2 - Participants will be randomized to receive a single injection.

Biological: Low dose of multivalent pneumococcal conjugate vaccine control

Standard dose multivalent pneumococcal conjugate vaccine control

ACTIVE COMPARATOR

Control - Stages 1 and 2 - Participants will be randomized to receive a single injection.

Biological: Standard dose multivalent pneumococcal conjugate vaccine control

Interventions

Low dose multivalent pneumococcal conjugate vaccine formulation A OTHER

Biological

Low dose multivalent pneumococcal conjugate vaccine formulation A

Low dose multivalent pneumococcal conjugate vaccine formulation B OTHER

Biological

Low dose multivalent pneumococcal conjugate vaccine formulation B

Low dose of multivalent pneumococcal conjugate vaccine control BIOLOGICAL

low dose multivalent pneumococcal conjugate vaccine

Also known as: Primary control

Low dose of multivalent pneumococcal conjugate vaccine control

Standard dose multivalent pneumococcal conjugate vaccine control BIOLOGICAL

multivalent pneumococcal conjugate vaccine

Also known as: Control

Standard dose multivalent pneumococcal conjugate vaccine control

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Centennial Medical Group

Columbia, Maryland, 21045, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, 78229, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: April 19, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)