Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Study Details
Study Description
Brief Summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days postvaccination. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cohort 1 V116 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1. |
Biological: V116
Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
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Active Comparator: Cohort 1 PCV20 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1. |
Biological: PCV20
Sterile 0.5 mL suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.
Other Names:
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Experimental: Cohort 2 V116 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1. |
Biological: V116
Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
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Active Comparator: Cohort 2 PCV20 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1. |
Biological: PCV20
Sterile 0.5 mL suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percentage of participants with solicited injection-site AEs [Up to 5 days postvaccination]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of pain/tenderness, redness/erythema, and swelling.
- Percentage of participants with solicited systemic AEs [Up to 5 days postvaccination]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of headache, muscle aches/myalgia, and tiredness/fatigue.
- Percentage of participants with vaccine-related serious AE (SAE) [Up to 194 days postvaccination]
A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event.
- Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohort 1 for the 21 serotypes contained in V116 [Day 30 postvaccination]
The serotype-specific OPA GMTs for the 21 serotypes contained in V116 will be determined using the multiplex opsonophagocytic assay (MOPA).
- Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs in Cohort 1 for for the 21 serotypes contained in V116 [Baseline and Day 30 postvaccination]
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 21 serotypes contained in V116 will be determined.
Secondary Outcome Measures
- Serotype-specific OPA GMTs in Cohorts 1 and 2 [Day 30 postvaccination]
The serotype-specific OPA GMTs will be determined using MOPA.
- Percentage of participants with ≥4-fold rise in serotype-specific cross-reactive OPA responses in Cohorts 1 and 2 [Day 30 postvaccination]
The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs will be determined.
- Serotype-specific cross-reactive OPA GMTs in Cohorts 1 and 2 [Day 30 postvaccination]
The serotype-specific OPA GMTs will be determined using MOPA.
- Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1 [Day 30 postvaccination]
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).
- Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs in Cohort 1 [Baseline and Day 30 postvaccination]
The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.
- GMFR from baseline in serotype-specific IgG GMCs in Cohort 1 [Baseline and Day 30 postvaccination]
The GMFR in GMCs for serotype-specific IgG antibodies will be determined using PnECL.
- Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs in Cohort 1 [Baseline and Day 30 postvaccination]
The GMFR in GMCs for serotype-specific IgG antibodies will be determined using PnECL.
- Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs in Cohort 1 [Baseline and Day 30 postvaccination]
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs will be determined.
Eligibility Criteria
Criteria
Inclusion Criteria:
- For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.
Exclusion Criteria:
- Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day
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Has a known hypersensitivity to any component of V116 or PCV20, including diphtheria toxoid
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Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
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Has a coagulation disorder contraindicating IM vaccination
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Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
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Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
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Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
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Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
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Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
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Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
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Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
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Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Central Research Associates ( Site 0067) | Birmingham | Alabama | United States | 35205 |
2 | Lenzmeier Family Medicine/CCT Research ( Site 0006) | Glendale | Arizona | United States | 85308 |
3 | Desert Clinical Research/ CCT Research ( Site 0040) | Mesa | Arizona | United States | 85213 |
4 | Foothills Research Center/ CCT Research ( Site 0021) | Phoenix | Arizona | United States | 85044 |
5 | Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003) | Tempe | Arizona | United States | 85283 |
6 | Baptist Health Center For Clinical Research ( Site 0019) | Little Rock | Arkansas | United States | 72205 |
7 | Southland Clinical Research Center-Research ( Site 0054) | Fountain Valley | California | United States | 92708 |
8 | Sunwise Clinical Research ( Site 0024) | Lafayette | California | United States | 94549 |
9 | Chemidox Clinical Trials ( Site 0048) | Lancaster | California | United States | 93534 |
10 | Paradigm Clinical Research Centers, Inc ( Site 0018) | Redding | California | United States | 96001 |
11 | Peninsula Research Associates ( Site 0079) | Rolling Hills Estates | California | United States | 90274 |
12 | Acclaim Clinical Research ( Site 0083) | San Diego | California | United States | 92120 |
13 | Millennium Clinical Trials ( Site 0013) | Simi Valley | California | United States | 93065 |
14 | Lynn Institute of Denver ( Site 0012) | Aurora | Colorado | United States | 80012 |
15 | Paradigm Clinical Research Centers, Inc ( Site 0027) | Wheat Ridge | Colorado | United States | 80033 |
16 | JEM Research Institute ( Site 0072) | Atlantis | Florida | United States | 33462 |
17 | Alliance for Multispecialty Research, LLC ( Site 0015) | Coral Gables | Florida | United States | 33134 |
18 | Hillcrest Medical Research ( Site 0049) | DeLand | Florida | United States | 32720 |
19 | East Coast Institute for Research, LLC ( Site 0070) | Jacksonville | Florida | United States | 32204 |
20 | L&C Professional Medical Research Institute ( Site 0025) | Miami | Florida | United States | 33144 |
21 | Advanced Medical Research Institute ( Site 0014) | Miami | Florida | United States | 33174 |
22 | Headlands Research Orlando ( Site 0031) | Orlando | Florida | United States | 32819 |
23 | Genesis Clinical Research ( Site 0016) | Tampa | Florida | United States | 33603 |
24 | Clinical Research Trials of Florida ( Site 0007) | Tampa | Florida | United States | 33607 |
25 | Palm Beach Research Center ( Site 0060) | West Palm Beach | Florida | United States | 33409 |
26 | Clinical Research Prime ( Site 0010) | Idaho Falls | Idaho | United States | 83404 |
27 | Solaris Clinical Research ( Site 0008) | Meridian | Idaho | United States | 83646 |
28 | Versailles Family Medicine / CCT Research ( Site 0063) | Versailles | Kentucky | United States | 40383 |
29 | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038) | Troy | Michigan | United States | 48098 |
30 | Healor Primary Care / CCT Research ( Site 0056) | Las Vegas | Nevada | United States | 89102 |
31 | Excel Clinical Research, LLC ( Site 0077) | Las Vegas | Nevada | United States | 89109 |
32 | Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029) | Las Vegas | Nevada | United States | 89119 |
33 | Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032) | Horseheads | New York | United States | 14845 |
34 | Aventiv Research Inc ( Site 0044) | Columbus | Ohio | United States | 43213 |
35 | Advanced Medical Research ( Site 0002) | Maumee | Ohio | United States | 43537 |
36 | Lynn Institute of Norman ( Site 0001) | Norman | Oklahoma | United States | 73072 |
37 | Lynn Institute of Tulsa ( Site 0084) | Tulsa | Oklahoma | United States | 74135 |
38 | Summit Headlands ( Site 0047) | Portland | Oregon | United States | 97210 |
39 | Velocity Clinical Research, Greenville ( Site 0043) | Greenville | South Carolina | United States | 29615 |
40 | Trial Management Associates ( Site 0089) | Myrtle Beach | South Carolina | United States | 29572 |
41 | Tekton Research, Inc. ( Site 0053) | Austin | Texas | United States | 78745 |
42 | Elixir Research Group - W Houston ( Site 0068) | Houston | Texas | United States | 77077 |
43 | DCOL Center for Clinical Research ( Site 0051) | Longview | Texas | United States | 75605 |
44 | IMA Clinical Research San Antonio ( Site 0009) | San Antonio | Texas | United States | 78229 |
45 | VIP Trials ( Site 0086) | San Antonio | Texas | United States | 78230 |
46 | Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036) | Tomball | Texas | United States | 77375 |
47 | Charlottesville Medical Research ( Site 0034) | Charlottesville | Virginia | United States | 22911 |
48 | Health Research of Hampton Roads, Inc. ( Site 0004) | Newport News | Virginia | United States | 23606 |
49 | MultiCare Rockwood Cheney Clinic ( Site 0037) | Spokane | Washington | United States | 99204 |
50 | Paratus Clinical Research Canberra ( Site 3000) | Bruce | Australian Capital Territory | Australia | 2617 |
51 | Emeritus Research ( Site 3004) | Botany | New South Wales | Australia | 2019 |
52 | Paratus Clinical Research Central Coast ( Site 3001) | Kanwal | New South Wales | Australia | 2259 |
53 | Westmead Hospital ( Site 3005) | Westmead | New South Wales | Australia | 2145 |
54 | Emeritus Research ( Site 3003) | Camberwell | Victoria | Australia | 3124 |
55 | InfektioResearch ( Site 1203) | Frankfurt | Hessen | Germany | 60596 |
56 | Hamburger Institut fuer Therapieforschung GmbH ( Site 1204) | Hamburg | Germany | 20354 | |
57 | Lakeland Clinical Trials ( Site 3102) | Rotorua | Bay Of Plenty | New Zealand | 3010 |
58 | P3 Research - Tauranga ( Site 3100) | Tauranga | Bay Of Plenty | New Zealand | 3110 |
59 | Southern Clinical Trials Ltd ( Site 3104) | Christchurch | Canterbury | New Zealand | 8013 |
60 | Southern Clinical Trials Waitemata Ltd ( Site 3105) | Auckland | New Zealand | 0626 | |
61 | P3 Research - Wellington ( Site 3101) | Wellington | New Zealand | 6021 | |
62 | Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601) | Bayamon | Puerto Rico | 00961 | |
63 | San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606) | Caguas | Puerto Rico | 00725 | |
64 | Clinical Research Investigator Group ( Site 0611) | Canovanas | Puerto Rico | 00729 | |
65 | Ponce School Of Medicine Caimed Center ( Site 0602) | Ponce | Puerto Rico | 00716 | |
66 | Clinical Research Puerto Rico ( Site 0600) | San Juan | Puerto Rico | 00909 | |
67 | National Cheng Kung University Hospital ( Site 3301) | Tainan | Taiwan | 704 | |
68 | Chang Gung Medical Foundation-Linkou Branch ( Site 3303) | Taoyuan | Taiwan | 333 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp and Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V116-003
- V116-003
- 2022-000258-27