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

NCT06177912 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: V116-013jRCT20312305592023-506236-32U1111-1293-4944
• Study Type: interventional
• Target: 882
• Locations: 13 countries
• Sites: 92

Brief Summary

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).

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination

  30 days postvaccination

• Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs

  Baseline (Day 1) and 30 days postvaccination

• Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs

  Baseline (Day 1) and Day 30 postvaccination

• GMFR From Baseline in Serotype-specific IgG GMCs

  Baseline (Day 1) and Day 30 postvaccination

• Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs

  Baseline (Day 1) and Day 30 postvaccination

Study Arms (2)

V116

EXPERIMENTAL

Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1

Biological: V116

PPSV23

ACTIVE COMPARATOR

Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.

Biological: PPSV23

Interventions

V116 BIOLOGICAL

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

Also known as: Pneumococcal 21-valent Conjugate Vaccine

V116

PPSV23 BIOLOGICAL

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

Also known as: PNEUMOVAX™23

PPSV23

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (92)

Central Research Associates ( Site 0145)

Birmingham, Alabama, 35205, United States

Location

Velocity Clinical Research, Phoenix ( Site 0122)

Phoenix, Arizona, 85006, United States

Location

Madera Family Medical Group ( Site 0120)

Madera, California, 93637, United States

Location

Optumcare Colorado Springs, LLC ( Site 0113)

Colorado Springs, Colorado, 80922, United States

Location

Accel Research Sites Network- Nona Pediatric Center ( Site 0109)

Orlando, Florida, 32829, United States

Location

University of South Florida-Department of Pediatrics ( Site 0110)

Tampa, Florida, 33606, United States

Location

Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)

Macon, Georgia, 31210, United States

Location

Bingham Memorial Hospital ( Site 0149)

Blackfoot, Idaho, 83221, United States

Location

Clinical Research Prime ( Site 0105)

Idaho Falls, Idaho, 83404, United States

Location

Clinical Research Prime Rexburg ( Site 0104)

Rexburg, Idaho, 83440, United States

Location

University of Louisville, Norton Children's Research Institute ( Site 0148)

Louisville, Kentucky, 40202, United States

Location

Velocity Clinical Research, Lafayette ( Site 0103)

Lafayette, Louisiana, 70508, United States

Location

Velocity Clinical Research, Gulfport ( Site 0115)

Gulfport, Mississippi, 39503, United States

Location

Velocity Clinical Research, Hastings ( Site 0114)

Hastings, Nebraska, 68901, United States

Location

Midwest Children's Health Research Institute ( Site 0117)

Lincoln, Nebraska, 68504, United States

Location

Midwest Children's Health Research Institute ( Site 0106)

Lincoln, Nebraska, 68505, United States

Location

Midwest Children's Health Research Institute-Research ( Site 0119)

Lincoln, Nebraska, 68516, United States

Location

Midwest Children's Health Research Institute-Research ( Site 0102)

Lincoln, Nebraska, 68522, United States

Location

Velocity Clinical Research, Albuquerque ( Site 0112)

Albuquerque, New Mexico, 87107, United States

Location

Velocity Clinical Research, Vestal ( Site 0121)

Vestal, New York, 13850, United States

Location

Epic Medical Research - Oklahoma ( Site 0134)

Chickasha, Oklahoma, 73018, United States

Location

Tribe Clinical Research, LLC-Pediatrics ( Site 0118)

Greenville, South Carolina, 29607, United States

Location

Tribe Clinical Research - Spartanburg ( Site 0108)

Spartanburg, South Carolina, 29301, United States

Location

Velocity Clinical Research, Austin ( Site 0129)

Austin, Texas, 78759, United States

Location

PanAmerican Clinical Research ( Site 0132)

Brownsville, Texas, 78521, United States

Location

Epic Medical Research ( Site 0133)

DeSoto, Texas, 75115, United States

Location

Epic Medical Research - Mesquite ( Site 0144)

Mesquite, Texas, 75150, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0140)

Layton, Utah, 84041, United States

Location

Velocity Clinical Research, Salt Lake City ( Site 0124)

West Jordan, Utah, 84088, United States

Location

Canadian Center for Vaccinology ( Site 0004)

Halifax, Nova Scotia, B3K6R8, Canada

Location

Premier Clinical Trial Network ( Site 0008)

Hamilton, Ontario, L8L 5G4, Canada

Location

Children's Hospital of Eastern Ontario ( Site 0001)

Ottawa, Ontario, K1H 8L1, Canada

Location

CHU Sainte-Justine ( Site 0007)

Montreal, Quebec, H3T 1C5, Canada

Location

McGill University Health Centre - Vaccine Study Centre ( Site 0005)

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

CHU de Québec-Université Laval ( Site 0006)

Québec, Quebec, G1E 7G9, Canada

Location

Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)

Santiago, Region M. de Santiago, 7590943, Chile

Location

Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)

Santiago, Region M. de Santiago, 8330077, Chile

Location

Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)

Santiago, Region M. de Santiago, 8380418, Chile

Location

Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)

Santiago, Region M. de Santiago, 8880465, Chile

Location

Hospital Dr. Hernán Henríquez Aravena ( Site 0208)

Temuco, Región de la Araucanía, 4781151, Chile

Location

Clinica Somer ( Site 0405)

Rionegro, Antioquia, 054040, Colombia

Location

Oncomedica S.A.S ( Site 0402)

Montería, Departamento de Córdoba, 230001, Colombia

Location

Fundación Valle del Lili ( Site 0404)

Cali, Valle del Cauca Department, 760032, Colombia

Location

CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)

Cali, Valle del Cauca Department, 760042, Colombia

Location

FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)

Kokkola, Keski-Pohjanmaa, 67100, Finland

Location

FVR, Oulun rokotetutkimusklinikka ( Site 0600)

Oulu, North Ostrobothnia, 90220, Finland

Location

FVR, Tampereen rokotetutkimusklinikka ( Site 0603)

Tampere, Pirkanmaa, 33100, Finland

Location

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)

Seinäjoki, South Ostrobothnia, 60100, Finland

Location

FVR, Turun rokotetutkimusklinikka ( Site 0606)

Turku, Southwest Finland, 20520, Finland

Location

FVR, Espoon rokotetutkimusklinikka ( Site 0608)

Espoo, Uusimaa, 02230, Finland

Location

MeVac - Meilahti Vaccine Research Center ( Site 0609)

Helsinki, Uusimaa, 00290, Finland

Location

Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq

Caen, Calvados, 14033, France

Location

Hôpital Jeanne de Flandre ( Site 0702)

Lille, Nord, 59037, France

Location

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

Paris, 75019, France

Location

Rambam Health Care Campus ( Site 0900)

Haifa, 3109601, Israel

Location

Hadassah Mount Scopus Medical Centre ( Site 0902)

Jerusalem, 9124001, Israel

Location

Schneider Children's Medical Center ( Site 0903)

Petah Tikva, 4920235, Israel

Location

Saiseikai Yokohamashi Tobu Hospital ( Site 1714)

Yokohama, Kanagawa, 230-0012, Japan

Location

Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)

Kanegusuku, Okinawa, 901-1193, Japan

Location

Juntendo University Hospital ( Site 1700)

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Aquakids Clinic ( Site 1709)

Edogawa-ku, Tokyo, 133-0056, Japan

Location

Miyazaki Prefectural Miyazaki Hospital ( Site 1711)

Miyazaki, 880-8510, Japan

Location

University of Miyazaki Hospital ( Site 1705)

Miyazaki, 889-1692, Japan

Location

National Hospital Organization Okayama Medical Center ( Site 1713)

Okayama, 701-1192, Japan

Location

Saitama Prefectural Children's Medical Center ( Site 1702)

Saitama, 330-8777, Japan

Location

IN VIVO ( Site 1006)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

Location

Centrum Medyczne Pratia Bydgoszcz ( Site 1004)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc

Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

Location

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)

Łomianki, Masovian Voivodeship, 05-092, Poland

Location

Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)

Lodz, Łódź Voivodeship, 91-347, Poland

Location

Hospital Germans Trias i Pujol ( Site 1104)

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Joan de Déu ( Site 1113)

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitari Vall d'Hebron ( Site 1115)

Barcelona, Catalonia, 08035, Spain

Location

CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital Universitario Severo Ochoa ( Site 1114)

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11

Madrid, 28041, Spain

Location

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)

Seville, 41013, Spain

Location

CTC Karolinska ( Site 1201)

Solna, Stockholm County, 171 64, Sweden

Location

Norrlands universitetssjukhus ( Site 1200)

Umeå, Västerbotten County, 901 85, Sweden

Location

CTC GoCo ( Site 1202)

Mölndal, Västra Götaland County, 431 53, Sweden

Location

Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)

Bangkoknoi, Bangkok, 10700, Thailand

Location

Chulalongkorn University-Pediatrics ( Site 1602)

Pathumwan, Bangkok, 10330, Thailand

Location

Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)

Ratchathewi, Bangkok, 10400, Thailand

Location

Songklanagarind hospital-Department of Pediatrics ( Site 1603)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)

Sarçam, Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri ( Site 1300)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)

Ankara, 06590, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)

Ankara, 06800, Turkey (Türkiye)

Location

Sisli Etfal Training and Research Hospital ( Site 1305)

Istanbul, 34360, Turkey (Türkiye)

Location

Ege Universitesi Hastanesi ( Site 1306)

Izmir, 35100, Turkey (Türkiye)

Location

Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)

Kayseri, 38039, Turkey (Türkiye)

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 18, 2024
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); PL (5); ES (8); SE (3); CO (4); TH (4); JP (8); TU (7); FI (7); CA (6); IL (3); CL (5); US (29)