This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
253
V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.
Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.
Percentage of Participants With an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to Day 44 after vaccination
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.
Time frame: Up to Day 5 after vaccination
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
Time frame: Up to Day 14 after vaccination
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.
Time frame: Baseline (Day 1) and Day 30 after vaccination
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
The GMFR (Day 30 geometric mean concentration \[GMC\] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Time frame: Baseline (Day 1) and Day 30 after vaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
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Time frame: Baseline (Day 1) and Day 30 after vaccination
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4).
Time frame: Baseline (Day 1) and Day 30 after vaccination
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Time frame: Baseline (Day 1) and Day 30 after vaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Time frame: Baseline (Day 1) and Day 30 after vaccination