Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: V114
* Biological: Prevnar 13™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is in good health (any underlying chronic illness must be documented to be in stable condition) Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry Is a male or postmenopausal female Exclusion Criteria: Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine Is known or suspected impairment of immune function Has received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination Has a coagulation disorder contraindicating intramuscular vaccination Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion Has participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V114<br>Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of V114 on Day 1. | Biological: V114<br>* 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.<br>|
| Active Comparator: Prevnar 13™<br>Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. | Biological: Prevnar 13™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Day 1) and Day 30 after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | Baseline (Day 1) and Day 30 after vaccination |