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

Phase 1

Completed

Conditions: Pneumococcal Disease

Interventions: Other: Candidate-4
Biological: 13vPnC
Other: Candidate-2
Other: Candidate-3
Other: Candidate-5
Other: Candidate Control
Biological: PCV15
Other: Candidate-1
Other: Candidate-6

Registration Number: NCT05489328

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 394

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Candidate-4	Candidate-4	Participants to receive a single injection of Candidate-4.
13-valent pneumococcal conjugate vaccine (13vPnC)	13vPnC	Participants to receive a single injection of 13vPnC.
Candidate-2	Candidate-2	Participants to receive a single injection of Candidate-2.
Candidate-3	Candidate-3	Participants to receive a single injection of Candidate-3.
Candidate-5	Candidate-5	Participants to receive a single injection of Candidate-5.
Candidate Control	Candidate Control	Participants to receive a single injection of Candidate Control.
15-valent pneumococcal conjugate vaccine (PCV15)	PCV15	Participants to receive a single injection of PCV15.
Candidate-1	Candidate-1	Participants to receive a single injection of Candidate-1.
Candidate-6	Candidate-6	Participants to receive a single injection of Candidate-6.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention	Within 1 month after 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.
Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention	Within 7 days after 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.
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention	Within 7 days after 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.
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention	Within 1 month after 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.

Secondary Outcome Measures

Name	Time	Method
Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group	1 month after study intervention	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).

Trial Locations

Locations (18): DM Clinical Research
🇺🇸
Tomball, Texas, United States
Orange County Research Center
🇺🇸
Tustin, California, United States
Indago Research & Health Center, Inc
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Hialeah, Florida, United States
Diablo Clinical Research, Inc.
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Walnut Creek, California, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
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Troy, Michigan, United States
Alliance for Multispecialty Research, LLC
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Norfolk, Virginia, United States
Proactive Clinical Research,LLC
🇺🇸
Fort Lauderdale, Florida, United States
Clinical Research Consulting
🇺🇸
Milford, Connecticut, United States
Accellacare - Wilmington
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Wilmington, North Carolina, United States
Centennial Medical Group
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Elkridge, Maryland, United States
Clinical Trials of Texas, LLC
🇺🇸
San Antonio, Texas, United States
Diagnostics Research Group
🇺🇸
San Antonio, Texas, United States
IMA Clinical Research San Antonio
🇺🇸
San Antonio, Texas, United States
South Jersey Infectious Disease
🇺🇸
Somers Point, New Jersey, United States
Prism Research LLC dba Nucleus Network
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Saint Paul, Minnesota, United States
Qps-Mra, Llc
🇺🇸
South Miami, Florida, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸
Salt Lake City, Utah, United States