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

Pneumococcal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05489328
• Other study ID #: C4801001
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2022
• Est. completion date: October 7, 2022

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Other:
• Candidate-1
Biological
• Candidate-2
Biological
• Candidate-3
Biological
• Candidate-4
Biological
• Candidate-5
Biological
• Candidate-6
Biological
• Candidate Control
Biological

Biological:
• 13vPnC
13-valent pneumococcal conjugate vaccine
• PCV15
15-valent pneumococcal conjugate vaccine

Locations

Country	Name	City	State
United States	Centennial Medical Group	Elkridge	Maryland
United States	Proactive Clinical Research,LLC	Fort Lauderdale	Florida
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	Clinical Research Consulting	Milford	Connecticut
United States	Alliance for Multispecialty Research, LLC	Norfolk	Virginia
United States	Prism Research LLC dba Nucleus Network	Saint Paul	Minnesota
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	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	Qps-Mra, Llc	South Miami	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	Orange County Research Center	Tustin	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Accellacare - Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

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