Back to resultsA 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.
Primary Purpose
Pneumococcal Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low dose multivalent pneumococcal conjugate vaccine formulation A
Low dose multivalent pneumococcal conjugate vaccine formulation B
Low dose of multivalent pneumococcal conjugate vaccine control
Standard dose multivalent pneumococcal conjugate vaccine control
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease
Eligibility Criteria
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
Sites / Locations
- Indago Research & Health Center, IncRecruiting
- Research Centers of America ( Hollywood )Recruiting
- Centennial Medical GroupRecruiting
- Velocity Clinical Research, OmahaRecruiting
- Rochester Clinical Research, LLCRecruiting
- Clinical Trials of Texas, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Low dose multivalent pneumococcal conjugate vaccine formulation A
Low dose multivalent pneumococcal conjugate vaccine formulation B
Low dose of multivalent pneumococcal conjugate vaccine control
Standard dose multivalent pneumococcal conjugate vaccine control
Arm Description
Stage 1 and Stage 3 if selected - Participants will be randomized to receive a single injection.
Stage 2 and Stage 3 if selected - Participants will be randomized to receive a single injection.
Primary control - Stages 1, 2, and 3 - Participants will be randomized to receive a single injection.
Control - Stages 1, 2, and 3 - Participants will be randomized to receive a single injection.
Outcomes
Primary Outcome Measures
Percentage of participants reporting local reactions within 7 days after vaccination
Local reactions (redness, swelling, pain at the injection site) after vaccination.
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.
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Adverse Events occurring within 1 month after vaccination.
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
SAEs occurring within 6 months after vaccination.
Percentage of participants reporting Serious Adverse Events (SAEs) withing 12 months after vaccination
SAEs occurring within 12 months after vaccination.
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) within 6 months after vaccination
NDCMCs occurring within 6 months after vaccination.
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) withing 12 months after vaccination
NDCMCs occurring within 12 months after vaccination.
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination
MAAEs occurring within 6 months after vaccination.
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination
MAAEs occurring within 12 months after vaccination.
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.
Secondary Outcome Measures
Pneumococcal opsonophagocytic activity (OPA) titers
OPA geometric mean titers (GMTs) 1 month after vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05831124
Brief Title
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.
Official Title
A Phase 1, Randomized, Double-Blind Study of the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine With a Novel Adjuvant Administered in Adults 50 Through 64 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
November 12, 2024 (Anticipated)
Study Completion Date
November 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose multivalent pneumococcal conjugate vaccine formulation A
Arm Type
Experimental
Arm Description
Stage 1 and Stage 3 if selected - Participants will be randomized to receive a single injection.
Arm Title
Low dose multivalent pneumococcal conjugate vaccine formulation B
Arm Type
Experimental
Arm Description
Stage 2 and Stage 3 if selected - Participants will be randomized to receive a single injection.
Arm Title
Low dose of multivalent pneumococcal conjugate vaccine control
Arm Type
Active Comparator
Arm Description
Primary control - Stages 1, 2, and 3 - Participants will be randomized to receive a single injection.
Arm Title
Standard dose multivalent pneumococcal conjugate vaccine control
Arm Type
Active Comparator
Arm Description
Control - Stages 1, 2, and 3 - Participants will be randomized to receive a single injection.
Intervention Type
Other
Intervention Name(s)
Low dose multivalent pneumococcal conjugate vaccine formulation A
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Low dose multivalent pneumococcal conjugate vaccine formulation B
Intervention Description
Biological
Intervention Type
Biological
Intervention Name(s)
Low dose of multivalent pneumococcal conjugate vaccine control
Other Intervention Name(s)
Primary control
Intervention Description
low dose multivalent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Standard dose multivalent pneumococcal conjugate vaccine control
Other Intervention Name(s)
Control
Intervention Description
multivalent pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of participants reporting local reactions within 7 days after vaccination
Description
Local reactions (redness, swelling, pain at the injection site) after vaccination.
Time Frame
7 days
Title
Percentage of participants reporting systemic events within 7 days after vaccination
Description
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain, and joint pain) after vaccination.
Time Frame
7 days
Title
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Description
Adverse Events occurring within 1 month after vaccination.
Time Frame
1 month
Title
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
Description
SAEs occurring within 6 months after vaccination.
Time Frame
6 months
Title
Percentage of participants reporting Serious Adverse Events (SAEs) withing 12 months after vaccination
Description
SAEs occurring within 12 months after vaccination.
Time Frame
12 months
Title
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) within 6 months after vaccination
Description
NDCMCs occurring within 6 months after vaccination.
Time Frame
6 months
Title
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) withing 12 months after vaccination
Description
NDCMCs occurring within 12 months after vaccination.
Time Frame
12 months
Title
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination
Description
MAAEs occurring within 6 months after vaccination.
Time Frame
6 months
Title
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination
Description
MAAEs occurring within 12 months after vaccination.
Time Frame
12 months
Title
Stage 1 and Stage 2 Only - Percentage of participants with abnormal hematology and chemistry laboratory values 2 weeks after vaccination
Description
Abnormal hematology and chemistry laboratory values occurring 2 weeks after vaccination.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pneumococcal opsonophagocytic activity (OPA) titers
Description
OPA geometric mean titers (GMTs) 1 month after vaccination
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Centers of America ( Hollywood )
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Clinical Research, LLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4941001
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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.
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