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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
394
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 1 month after study intervention
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Biological
Biological
Biological
Biological
13-valent pneumococcal conjugate vaccine
15-valent pneumococcal conjugate vaccine
Clinical Research Consulting
Milford, Connecticut, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Centennial Medical Group
Elkridge, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
...and 8 more locations
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.
Time frame: Within 1 month after study intervention
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).
Time frame: 1 month after study intervention