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

PHASE3CompletedINTERVENTIONAL
Enrollment

882

Participants

Timeline

Start Date

January 18, 2024

Primary Completion Date

February 26, 2025

Study Completion Date

February 26, 2025

Conditions
Pneumococcal Infection
Interventions
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

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

Trial Locations (92)

10330

Chulalongkorn University-Pediatrics ( Site 1602), Pathumwan

10400

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

10700

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

13850

Velocity Clinical Research, Vestal ( Site 0121), Vestal

14033

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

15706

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

20520

FVR, Turun rokotetutkimusklinikka ( Site 0606), Turku

28041

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

28046

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

28911

Hospital Universitario Severo Ochoa ( Site 1114), Leganés

29301

Tribe Clinical Research - Spartanburg ( Site 0108), Spartanburg

29607

Tribe Clinical Research, LLC-Pediatrics ( Site 0118), Greenville

31210

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

32829

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

33100

FVR, Tampereen rokotetutkimusklinikka ( Site 0603), Tampere

33606

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

34360

Sisli Etfal Training and Research Hospital ( Site 1305), Istanbul

35100

Ege Universitesi Hastanesi ( Site 1306), Izmir

35205

Central Research Associates ( Site 0145), Birmingham

38039

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

39503

Velocity Clinical Research, Gulfport ( Site 0115), Gulfport

40202

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

41013

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112), Seville

59037

Hôpital Jeanne de Flandre ( Site 0702), Lille

60100

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604), Seinäjoki

67100

FVR, Kokkolan rokotetutkimusklinikka ( Site 0602), Kokkola

68504

Midwest Children's Health Research Institute ( Site 0117), Lincoln

68505

Midwest Children's Health Research Institute ( Site 0106), Lincoln

68516

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

68522

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

68901

Velocity Clinical Research, Hastings ( Site 0114), Hastings

70508

Velocity Clinical Research, Lafayette ( Site 0103), Lafayette

73018

Epic Medical Research - Oklahoma ( Site 0134), Chickasha

75019

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

75115

Epic Medical Research ( Site 0133), DeSoto

75150

Epic Medical Research - Mesquite ( Site 0144), Mesquite

78521

PanAmerican Clinical Research ( Site 0132), Brownsville

78759

Velocity Clinical Research, Austin ( Site 0129), Austin

80922

Optumcare Colorado Springs, LLC ( Site 0113), Colorado Springs

83221

Bingham Memorial Hospital ( Site 0149), Blackfoot

83404

Clinical Research Prime ( Site 0105), Idaho Falls

83440

Clinical Research Prime Rexburg ( Site 0104), Rexburg

84041

Alliance for Multispecialty Research, LLC ( Site 0140), Layton

84088

Velocity Clinical Research, Salt Lake City ( Site 0124), West Jordan

85006

Velocity Clinical Research, Phoenix ( Site 0122), Phoenix

87107

Velocity Clinical Research, Albuquerque ( Site 0112), Albuquerque

90110

Songklanagarind hospital-Department of Pediatrics ( Site 1603), Hat Yai

90220

FVR, Oulun rokotetutkimusklinikka ( Site 0600), Oulu

93637

Madera Family Medical Group ( Site 0120), Madera

230001

Oncomedica S.A.S ( Site 0402), Montería

760032

Fundación Valle del Lili ( Site 0404), Santiago de Cali

760042

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

3109601

Rambam Health Care Campus ( Site 0900), Haifa

4781151

Hospital Dr. Hernán Henríquez Aravena ( Site 0208), Temuco

4920235

Schneider Children's Medical Center ( Site 0903), Petah Tikva

7590943

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

8330077

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

8380418

Hospital Roberto del Río-Infectología Pediátrica ( Site 0200), Santiago

8880465

Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204), Santiago

9124001

Hadassah Mount Scopus Medical Centre ( Site 0902), Jerusalem

B3K6R8

Canadian Center for Vaccinology ( Site 0004), Halifax

L8L 5G4

Premier Clinical Trial Network ( Site 0008), Hamilton

K1H 8L1

Children's Hospital of Eastern Ontario ( Site 0001), Ottawa

H3T 1C5

CHU Sainte-Justine ( Site 0007), Montreal

H9H 4Y6

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

G1E 7G9

CHU de Québec-Université Laval ( Site 0006), Québec

054040

Clinica Somer ( Site 0405), Rionegro

02230

FVR, Espoon rokotetutkimusklinikka ( Site 0608), Espoo

00290

MeVac - Meilahti Vaccine Research Center ( Site 0609), Helsinki

230-0012

Saiseikai Yokohamashi Tobu Hospital ( Site 1714), Yokohama

901-1193

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

113-8431

Juntendo University Hospital ( Site 1700), Bunkyo-ku

133-0056

Aquakids Clinic ( Site 1709), Edogawa-ku

880-8510

Miyazaki Prefectural Miyazaki Hospital ( Site 1711), Miyazaki

889-1692

University of Miyazaki Hospital ( Site 1705), Miyazaki

701-1192

National Hospital Organization Okayama Medical Center ( Site 1713), Okayama

330-8777

Saitama Prefectural Children's Medical Center ( Site 1702), Saitama

85-048

IN VIVO ( Site 1006), Bydgoszcz

85-796

Centrum Medyczne Pratia Bydgoszcz ( Site 1004), Bydgoszcz

50-368

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

05-092

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

91-347

Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005), Lodz

08916

Hospital Germans Trias i Pujol ( Site 1104), Badalona

08950

Hospital Sant Joan de Déu ( Site 1113), Esplugues de Llobregat

08035

Hospital Universitari Vall d'Hebron ( Site 1115), Barcelona

171 64

CTC Karolinska ( Site 1201), Solna

901 85

Norrlands universitetssjukhus ( Site 1200), Umeå

431 53

CTC GoCo ( Site 1202), Mölndal

01250

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

06230

Hacettepe Universite Hastaneleri ( Site 1300), Ankara

06590

Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304), Ankara

06800

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

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT06177912 - A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) | Biotech Hunter | Biotech Hunter