The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

Study Overview
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Brief Summary
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The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older. The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.

Official Title
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A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and PREVNAR 13® (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Pneumococcal Conjugate Vaccine (V114)
* Biological: PNEUMOVAX® 23
* Biological: PREVNAR 13®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Without fever for 72 hours prior to vaccination Exclusion Criteria: Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine Known or suspected to be immunocompromised Functional or anatomic asplenia History of autoimmune disease Evidence of dementia or cognitive impairment Use of any immunosuppressive therapy Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine

Ages Eligible for Study
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Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V114<br>Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. | Biological: Pneumococcal Conjugate Vaccine (V114)<br>* 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.<br>|
| Active Comparator: PNEUMOVAX® 23<br>Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1. | Biological: PNEUMOVAX® 23<br>* 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.<br>|
| Active Comparator: PREVNAR 13®<br>Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1. | Biological: PREVNAR 13®<br>* 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL 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 | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. | All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination | 
| Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed. | Up to Day 14 postvaccination | 
| Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed. | Up to Day 14 postvaccination | 
| Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. | Up to 6 months postvaccination | 
| Percentage of Participants With a Vaccine-related Serious Adverse Event | A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported. | Up to 6 months postvaccination | 
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay. | One month postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4) | One month postvaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal vaccines