Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Other: Candidate-1; Other: Candidate-2; Other: Candidate-3; Other: Candidate-4; Other: Candidate-5; Other: Candidate-6; Other: Candidate Control; Biological: 13vPnC; Biological: PCV15

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Proactive Clinical Research,LLC
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
  • Michigan
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Prism Research LLC dba Nucleus Network
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • South Jersey Infectious Disease
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington
  • Texas
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC
    • San Antonio, Texas, United States, 78229
      • IMA Clinical Research San Antonio
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc. / Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Alliance for Multispecialty Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female participants ≥18 and ≤49 years of age at the time of consent
• Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
• Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children

Exclusion Criteria:

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
• Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
• Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
• Known or suspected immunodeficiency or other conditions associated with immunosuppression
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Candidate-1; Participants to receive a single injection of Candidate-1.	Other: Candidate-1; Biological
Experimental: Candidate-2; Participants to receive a single injection of Candidate-2.	Other: Candidate-2; Biological
Experimental: Candidate-3; Participants to receive a single injection of Candidate-3.	Other: Candidate-3; Biological
Experimental: Candidate-4; Participants to receive a single injection of Candidate-4.	Other: Candidate-4; Biological
Experimental: Candidate-5; Participants to receive a single injection of Candidate-5.	Other: Candidate-5; Biological
Experimental: Candidate-6; Participants to receive a single injection of Candidate-6.	Other: Candidate-6; Biological
Active Comparator: Candidate Control; Participants to receive a single injection of Candidate Control.	Other: Candidate Control; Biological
Other: 13-valent pneumococcal conjugate vaccine (13vPnC); Participants to receive a single injection of 13vPnC.	Biological: 13vPnC; 13-valent pneumococcal conjugate vaccine
Other: 15-valent pneumococcal conjugate vaccine (PCV15); Participants to receive a single injection of PCV15.	Biological: PCV15; 15-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention	Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (>) 2.0 cm to 5.0 cm, moderate: >5.0 cm to 10.0 cm and severe > 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.	Within 7 days after study intervention
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention	Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.	Within 7 days after study intervention
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention	An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.	Within 1 month after study intervention
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention	An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.	Within 1 month after study intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group	GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution).	1 month after study intervention

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): August 15, 2022
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 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
• Other Study ID Numbers: C4801001

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