A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (STRIDE-13)

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting pneumococcal disease (PD).

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infection
• Intervention / Treatment: Biological: PPSV23; Biological: V116

• Study Type: Interventional
• Enrollment (Actual): 882
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K6R8
      • Canadian Center for Vaccinology ( Site 0004)
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G4
      • Premier Clinical Trial Network ( Site 0008)
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario ( Site 0001)
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine ( Site 0007)
    • Pierrefonds, Quebec, Canada, H9H 4Y6
      • McGill University Health Centre - Vaccine Study Centre ( Site 0005)
    • Québec, Quebec, Canada, G1E 7G9
      • CHU de Québec-Université Laval ( Site 0006)
• Chile
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7590943
      • Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)
    • Santiago, Region M. de Santiago, Chile, 8330077
      • Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)
    • Santiago, Region M. de Santiago, Chile, 8380418
      • Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)
    • Santiago, Region M. de Santiago, Chile, 8880465
      • Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4781151
      • Hospital Dr. Hernán Henríquez Aravena ( Site 0208)
• Colombia
  • Antioquia
    • Rionegro, Antioquia, Colombia, 054040
      • Clinica Somer ( Site 0405)
  • Departamento de Córdoba
    • Montería, Departamento de Córdoba, Colombia, 230001
      • Oncomedica S.A.S ( Site 0402)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760032
      • Fundación Valle del Lili ( Site 0404)
    • Cali, Valle del Cauca Department, Colombia, 760042
      • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)
• Finland
  • Keski-Pohjanmaa
    • Kokkola, Keski-Pohjanmaa, Finland, 67100
      • FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)
  • North Ostrobothnia
    • Oulu, North Ostrobothnia, Finland, 90220
      • FVR, Oulun rokotetutkimusklinikka ( Site 0600)
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33100
      • FVR, Tampereen rokotetutkimusklinikka ( Site 0603)
  • South Ostrobothnia
    • Seinäjoki, South Ostrobothnia, Finland, 60100
      • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • FVR, Turun rokotetutkimusklinikka ( Site 0606)
  • Uusimaa
    • Espoo, Uusimaa, Finland, 02230
      • FVR, Espoon rokotetutkimusklinikka ( Site 0608)
    • Helsinki, Uusimaa, Finland, 00290
      • MeVac - Meilahti Vaccine Research Center ( Site 0609)
• France
  • Paris, France, 75019
    • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
  • Calvados
    • Caen, Calvados, France, 14033
      • Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
  • Nord
    • Lille, Nord, France, 59037
      • Hôpital Jeanne de Flandre ( Site 0702)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 0900)
  • Jerusalem, Israel, 9124001
    • Hadassah Mount Scopus Medical Centre ( Site 0902)
  • Petah Tikva, Israel, 4920235
    • Schneider Children's Medical Center ( Site 0903)
• Japan
  • Miyazaki, Japan, 880-8510
    • Miyazaki Prefectural Miyazaki Hospital ( Site 1711)
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital ( Site 1705)
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center ( Site 1713)
  • Saitama, Japan, 330-8777
    • Saitama Prefectural Children's Medical Center ( Site 1702)
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 230-0012
      • Saiseikai Yokohamashi Tobu Hospital ( Site 1714)
  • Okinawa
    • Kanegusuku, Okinawa, Japan, 901-1193
      • Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital ( Site 1700)
    • Edogawa-ku, Tokyo, Japan, 133-0056
      • Aquakids Clinic ( Site 1709)
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
      • IN VIVO ( Site 1006)
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Centrum Medyczne Pratia Bydgoszcz ( Site 1004)
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-368
      • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc
  • Masovian Voivodeship
    • Łomianki, Masovian Voivodeship, Poland, 05-092
      • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 91-347
      • Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11
  • Seville, Spain, 41013
    • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol ( Site 1104)
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu ( Site 1113)
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall d'Hebron ( Site 1115)
  • La Coruna
    • Santiago de Compostela, La Coruna, Spain, 15706
      • CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)
  • Madrid
    • Leganés, Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa ( Site 1114)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28046
      • Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)
• Sweden
  • Stockholm County
    • Solna, Stockholm County, Sweden, 171 64
      • CTC Karolinska ( Site 1201)
  • Västerbotten County
    • Umeå, Västerbotten County, Sweden, 901 85
      • Norrlands universitetssjukhus ( Site 1200)
  • Västra Götaland County
    • Mölndal, Västra Götaland County, Sweden, 431 53
      • CTC GoCo ( Site 1202)
• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)
    • Pathumwan, Bangkok, Thailand, 10330
      • Chulalongkorn University-Pediatrics ( Site 1602)
    • Ratchathewi, Bangkok, Thailand, 10400
      • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)
  • Changwat Songkhla
    • Hat Yai, Changwat Songkhla, Thailand, 90110
      • Songklanagarind hospital-Department of Pediatrics ( Site 1603)
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universite Hastaneleri ( Site 1300)
  • Ankara, Turkey (Türkiye), 06590
    • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)
  • Istanbul, Turkey (Türkiye), 34360
    • Sisli Etfal Training and Research Hospital ( Site 1305)
  • Izmir, Turkey (Türkiye), 35100
    • Ege Universitesi Hastanesi ( Site 1306)
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)
  • Adana
    • Sarçam, Adana, Turkey (Türkiye), 01250
      • Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates ( Site 0145)
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research, Phoenix ( Site 0122)
  • California
    • Madera, California, United States, 93637
      • Madera Family Medical Group ( Site 0120)
  • Colorado
    • Colorado Springs, Colorado, United States, 80922
      • Optumcare Colorado Springs, LLC ( Site 0113)
  • Florida
    • Orlando, Florida, United States, 32829
      • Accel Research Sites Network- Nona Pediatric Center ( Site 0109)
    • Tampa, Florida, United States, 33606
      • University of South Florida-Department of Pediatrics ( Site 0110)
  • Georgia
    • Macon, Georgia, United States, 31210
      • Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Bingham Memorial Hospital ( Site 0149)
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime ( Site 0105)
    • Rexburg, Idaho, United States, 83440
      • Clinical Research Prime Rexburg ( Site 0104)
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, Norton Children's Research Institute ( Site 0148)
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research, Lafayette ( Site 0103)
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research, Gulfport ( Site 0115)
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Velocity Clinical Research, Hastings ( Site 0114)
    • Lincoln, Nebraska, United States, 68504
      • Midwest Children's Health Research Institute ( Site 0117)
    • Lincoln, Nebraska, United States, 68505
      • Midwest Children's Health Research Institute ( Site 0106)
    • Lincoln, Nebraska, United States, 68516
      • Midwest Children's Health Research Institute-Research ( Site 0119)
    • Lincoln, Nebraska, United States, 68522
      • Midwest Children's Health Research Institute-Research ( Site 0102)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • Velocity Clinical Research, Albuquerque ( Site 0112)
  • New York
    • Vestal, New York, United States, 13850
      • Velocity Clinical Research, Vestal ( Site 0121)
  • Oklahoma
    • Chickasha, Oklahoma, United States, 73018
      • Epic Medical Research - Oklahoma ( Site 0134)
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC-Pediatrics ( Site 0118)
    • Spartanburg, South Carolina, United States, 29301
      • Tribe Clinical Research - Spartanburg ( Site 0108)
  • Texas
    • Austin, Texas, United States, 78759
      • Velocity Clinical Research, Austin ( Site 0129)
    • Brownsville, Texas, United States, 78521
      • PanAmerican Clinical Research ( Site 0132)
    • DeSoto, Texas, United States, 75115
      • Epic Medical Research ( Site 0133)
    • Mesquite, Texas, United States, 75150
      • Epic Medical Research - Mesquite ( Site 0144)
  • Utah
    • Layton, Utah, United States, 84041
      • Alliance for Multispecialty Research, LLC ( Site 0140)
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City ( Site 0124)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.
• Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.

Exclusion Criteria:

• Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
• Has a history of active hepatitis within 3 months before study vaccination.
• Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination.
• Has a history of severely decreased kidney function dialysis, autoimmune related chronic kidney disease, nephrotic syndrome of any cause, or an acute/reversible cause of kidney disease.
• Has a history of severe pulmonary hypertension or history of Eisenmenger syndrome.
• History of invasive pneumococcal disease within 3 years before study vaccination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PPSV23; Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.	Biological: PPSV23; Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following 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; Other Names: PNEUMOVAX™23
Experimental: V116; Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1	Biological: V116; Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following 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; Other Names: Pneumococcal 21-valent Conjugate Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)	An AE was 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 included pain/tenderness, redness/erythema, and swelling.	Up to 5 days postvaccination
Percentage of Participants With Solicited Systemic AEs	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 included muscle aches all over the body (myalgia), headache, tiredness (fatigue), hives or welts (urticaria), irritability, joint pain (arthralgia), drowsiness (somnolence), feeling sick (malaise), and fever (pyrexia).	Up to 5 days post vaccination
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)	A vaccine-related 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.	Up to approximately 6 months
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses	Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	30 days postvaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination	The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific IgGs and GMC ratios with 95% CIs were calculated using a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	30 days postvaccination
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs	The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal OPA serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	Baseline (Day 1) and 30 days postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs	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 by the MOPA and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	Baseline (Day 1) and Day 30 postvaccination
GMFR From Baseline in Serotype-specific IgG GMCs	The GMFR from baseline in serotype-specific IgG GMCs was determined using PnECL at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F.	Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs	The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Titer levels were determined by PnECL and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	Baseline (Day 1) and Day 30 postvaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): February 26, 2025

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; 23-valent pneumococcal capsular polysaccharide vaccine
• Other Study ID Numbers: V116-013 (Other Identifier: MSD); jRCT2031230559 (Registry Identifier: jRCT); 2023-506236-32 (Registry Identifier: EU CT); U1111-1293-4944 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No