A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

NCT05420961 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: V116-006jRCT20712200252021-006679-41
• Study Type: interventional
• Target: 717
• Locations: 9 countries
• Sites: 51

Brief Summary

This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

Conditions

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Solicited Injection-site Adverse Events (AEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.

  Up to 5 days post-vaccination

• Percentage of Participants With Solicited Systemic AEs

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.

  Up to 5 days post-vaccination

• Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

  A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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 another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.

  Up to ~180 days

• Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)

  OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.

  30 Days post-vaccination

Secondary Outcomes (5)

• Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)

  30 Days post-vaccination

• Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)

  Day 1 (Baseline) and 30 days post-vaccination

• Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses

  Day 1 (Baseline) and 30 days post-vaccination

• Geometric Mean Fold Rise of Serotype-specific IgG

  Day 1 (Baseline) and 30 days post-vaccination

• Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response

  Day 1 (Baseline) and 30 days post-vaccination

Study Arms (5)

Cohort 1: V116

EXPERIMENTAL

Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.

Biological: V116

Cohort 1: PCV15

ACTIVE COMPARATOR

Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.

Biological: PCV15

Cohort 2: V116

EXPERIMENTAL

Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.

Biological: V116

Cohort 2: PPSV23

ACTIVE COMPARATOR

Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.

Biological: PPSV23

Cohort 3: V116

EXPERIMENTAL

Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.

Biological: V116

Interventions

V116 BIOLOGICAL

Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Also known as: Pneumococcal 21-valent Conjugate Vaccine

Cohort 1: V116; Cohort 2: V116; Cohort 3: V116

PCV15 BIOLOGICAL

Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension

Also known as: VAXNEUVANCE™

Cohort 1: PCV15

PPSV23 BIOLOGICAL

Pneumococcal 23-valent vaccine with 25 μg of each of the PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Also known as: PNEUMOVAX™23

Cohort 2: PPSV23

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Has received pneumococcal vaccine \>= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
• Has a history of invasive pneumococcal disease (IPD).
• Has a known hypersensitivity to any component of V116, PCV15, PCV20, 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 intramuscular vaccination.
• Has a known malignancy that is progressing or has required active treatment.
• Has received PPSV23 followed by either PCV15 or PCV20.
• Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
• 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.
• Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.
• Has 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.
• Has 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 post-vaccination blood draw is complete.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (51)

Central Research Associates ( Site 0024)

Birmingham, Alabama, 35205, United States

Location

Lenzmeier Family Medicine/CCT Research ( Site 0008)

Glendale, Arizona, 85308, United States

Location

Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)

Tempe, Arizona, 85283, United States

Location

Southland Clinical Research Center ( Site 0026)

Fountain Valley, California, 92708, United States

Location

Diablo Clinical Research, Inc. ( Site 0019)

Walnut Creek, California, 94598, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0020)

Coral Gables, Florida, 33134, United States

Location

Indago Research & Health Center, Inc ( Site 0005)

Hialeah, Florida, 33012, United States

Location

Advanced Medical Research Institute ( Site 0018)

Miami, Florida, 33174, United States

Location

Solaris Clinical Research ( Site 0025)

Meridian, Idaho, 83646, United States

Location

Centennial Medical Group ( Site 0002)

Elkridge, Maryland, 21075, United States

Location

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)

Troy, Michigan, 48098, United States

Location

Meridian Clinical Research, LLC ( Site 0009)

Norfolk, Nebraska, 68701, United States

Location

Advanced Medical Research ( Site 0001)

Maumee, Ohio, 43537, United States

Location

University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si

Galveston, Texas, 77555, United States

Location

Health Research of Hampton Roads, Inc. ( Site 0003)

Newport News, Virginia, 23606, United States

Location

Hamilton Medical Research Group ( Site 0114)

Hamilton, Ontario, L8M 1K7, Canada

Location

Milestone Research Inc. ( Site 0104)

London, Ontario, N5W 6A2, Canada

Location

Manna Research Mirabel ( Site 0109)

Mirabel, Quebec, J7J 2K8, Canada

Location

CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)

Québec, Quebec, G1E 7G9, Canada

Location

Diex Recherche Sherbrooke Inc. ( Site 0101)

Sherbrooke, Quebec, J1L 0H8, Canada

Location

CHU Bordeaux Haut-Leveque ( Site 0202)

Pessac, Aquitaine, 33600, France

Location

CHRU de Brest ( Site 0200)

Brest, Finistere, 29609, France

Location

centre hospitalier lyon sud ( Site 0204)

Pierre-Bénite, Rhone, 69310, France

Location

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)

Paris, 75679, France

Location

Rambam Health Care Campus ( Site 0303)

Haifa, 3109601, Israel

Location

Maccabi Health Services - Holon ( Site 0305)

Holon, Israel

Location

Maccabi Healthcare Services ( Site 0306)

Jerusalem, 71713, Israel

Location

Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)

Jerusalem, 9112001, Israel

Location

Meir Medical Center ( Site 0301)

Kfar Saba, 4428164, Israel

Location

Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)

Ramat Gan, 5265601, Israel

Location

Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)

Sakhnin, 3081000, Israel

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)

Milan, Lombardy, 20122, Italy

Location

Ospedale San Raffaele ( Site 0403)

Milan, Lombardy, 20132, Italy

Location

A.O.U. Policlinico Paolo Giaccone ( Site 0402)

Palermo, Sicily, 90127, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)

Foggia, 71100, Italy

Location

PS Clinic ( Site 0700)

Fukuoka, 812-0025, Japan

Location

Nishikumamoto Hospital ( Site 0701)

Kumamoto, 861-4157, Japan

Location

Gachon University Gil Medical Center ( Site 0755)

Namdong-gu, Incheon, 21565, South Korea

Location

Korea University Ansan Hospital ( Site 0751)

Ansan-si, Kyonggi-do, 15355, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)

Seoul, 03312, South Korea

Location

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)

Seoul, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)

Seoul, 07441, South Korea

Location

Korea University Guro Hospital ( Site 0750)

Seoul, South Korea

Location

HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)

Barcelona, Catalonia, 08036, Spain

Location

EBA CENTELLES ( Site 0500)

Centelles, Catalonia, 08500, Spain

Location

Hospital Universitari de Bellvitge ( Site 0505)

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Internacional Xanit ( Site 0520)

Benalmádena, Malaga, 29630, Spain

Location

Hospital La Princesa ( Site 0515)

Madrid, 28006, Spain

Location

National Cheng Kung University Hospital ( Site 0801)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 0800)

Taipei, 100, Taiwan

Location

Related Publications (1)

• Scott P, Haranaka M, Choi JH, Stacey H, Dionne M, Greenberg D, Grijalva CG, Orenstein WA, Fernsler D, Gallagher N, Zeng T, Li J, Platt HL; STRIDE-6 Study Group. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6). Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.

  PMID: 39082735 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cohorts 1 and 2: participants, investigator, sponsor Cohort 3: no blinding
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: July 12, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: October 26, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

KR (6); ES (6); FR (4); IT (4); TW (2); JP (2); IL (7); CA (5); US (15)