Clinical trial NCT05569954: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)
Official title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 1484
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).


Eligibility 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 inclusion 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 1)
* Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
* 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
* Has a coagulation disorder contraindicating IM vaccination
* 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
* Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment
* Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
* 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
* 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
* 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)
* 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
* 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

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
timeFrame: Up to 5 days postvaccination
measure: Percentage of Participants With Solicited Systemic AEs
timeFrame: Up to 5 days postvaccination
measure: Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
timeFrame: Up to 6 months postvaccination
measure: Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116
timeFrame: Day 30 postvaccination
measure: Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116
timeFrame: Baseline (Day 1) and Day 30 postvaccination
Secondary outcomes:
measure: Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116
timeFrame: Day 30 postvaccination
measure: Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116
timeFrame: Baseline (Day 1) and Day 30 postvaccination
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos ( Site 0200)
state: Santa Fe
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney ( Site 1500)
state: New South Wales
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research ( Site 1502)
state: New South Wales
city: Albion
country: Australia
facility: Paratus Clinical Research Brisbane ( Site 1501)
state: Queensland
city: Barranquilla
country: Colombia
facility: IPS Centro Científico Asistencial S.A.S ( Site 0407)
state: Atlantico
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC ( Site 0415)
state: Valle Del Cauca
city: München
country: Germany
facility: klinikum rechts der isar der technischen universität münchen ( Site 0904)
state: Bayern
city: Frankfurt am Main
country: Germany
facility: InfektioResearch ( Site 0903)
state: Hessen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck ( Site 0902)
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 0900)
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 1002)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)
city: Kfar Saba
country: Israel
facility: Meir Medical Center-Infectious unit ( Site 1003)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1000)
city: Sakhnin
country: Israel
facility: Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001)
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital ( Site 1808)
state: Kang-won-do
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital-Infectious Diseases ( Site 1811)
state: Kwangju-Kwangyokshi
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital ( Site 1801)
state: Kyonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital ( Site 1812)
state: Kyonggi-do
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital ( Site 1813)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital ( Site 1810)
state: Pusan-Kwangyokshi
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804)
state: Taegu-Kwangyokshi
city: Jung-gu
country: Korea, Republic of
facility: Chungnam national university hospital ( Site 1814)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1809)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806)
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital ( Site 1807)
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 1800)
city: Palmerston North
country: New Zealand
facility: P3 Research - Palmerston North ( Site 1602)
state: Manawatu-Wanganui
city: Lower Hutt
country: New Zealand
facility: P3 Research - Lower Hutt ( Site 1601)
state: Wellington
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials ( Site 1600)
city: Centelles
country: Spain
facility: EBA CENTELLES ( Site 1100)
state: Cataluna
city: Getafe
country: Spain
facility: Hospital Universitario Getafe ( Site 1111)
state: Madrid, Comunidad De
city: València
country: Spain
facility: Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101)
city: Barcelona
country: Spain
facility: EAP Sardenya ( Site 1102)
city: Madrid
country: Spain
facility: Hospital La Princesa-Clinical Pharmacology ( Site 1115)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1901)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1900)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 1902)
city: Sancaktepe
country: Turkey
facility: Sancaktepe Şehit Prof.Dr. İlhan Varank Eğitim ve Arastirma Hastanesi ( Site 1305)
state: Istanbul
city: Ankara
country: Turkey
facility: ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-İnfection ( Site 1300)
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastalıkları ( Site
city: Istanbul
country: Turkey
facility: Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)
city: Shipley
country: United Kingdom
facility: Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)
state: Bradford
city: London
country: United Kingdom
facility: Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407)
state: England
city: London
country: United Kingdom
facility: Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402)
state: England
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre ( Site 1400)
state: Lancashire
city: Corby
country: United Kingdom
facility: Accellacare - Northamptonshire ( Site 1403)
state: Northamptonshire
city: Coventry
country: United Kingdom
facility: Accellacare - Warwickshire ( Site 1404)
state: Warwickshire
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: