Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,184

Participants

Timeline

Start Date

September 4, 2019

Primary Completion Date

August 5, 2021

Study Completion Date

August 5, 2021

Conditions
Pneumococcal Infections
Interventions
DRUG

Rotarix™

Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)

DRUG

Infanrix™ hexa

Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)

DRUG

V114

15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration,

DRUG

Prevenar 13™

13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.

Trial Locations (60)

3010

Vaccine and Immunisation Research Group - VIRGo ( Site 0002), Melbourne

4101

Queensland Children s Hospital ( Site 0004), South Brisbane

6009

Telethon Kids Institute ( Site 0003), Nedlands

8000

AZ Sint Jan Brugge-Oostende ( Site 0147), Bruges

8400

AZ Henry Serruys ( Site 0148), Ostend

8800

AZ Delta ( Site 0143), Roeselare

9000

AZ Maria Middelares Gent ( Site 0142), Ghent

UZ Gent ( Site 0141), Ghent

9300

O.L.V. Ziekenhuis Aalst ( Site 0144), Aalst

10617

Merekivi Perearstid ( Site 0165), Tallinn

Merelahe Perearstikeskus OU ( Site 0164), Tallinn

11313

Sinu Arst Tervisekeskus ( Site 0167), Tallinn

11315

Rosenthali Perearstikeskus OU ( Site 0166), Tallinn

15706

Hospital Clinico Universitario de Santiago ( Site 0109), Santiago de Compostela

22415

Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0065), Hamburg

28041

Hospital General Universitario 12 de Octubre ( Site 0106), Madrid

28046

Hospital Universitario La Paz ( Site 0107), Madrid

28050

Hospital Sanitas La Moraleja ( Site 0103), Madrid

29200

Hospital de Antequera ( Site 0111), Antequera

38448

Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0074), Wolfsburg

41014

Unidad de Estudios e Investigacion IHP ( Site 0101), Seville

41236

Kinderarztpraxis ( Site 0068), Mönchengladbach

45711

Praxis Dr. Schmute ( Site 0078), Datteln

46022

C.S. Serreria II ( Site 0116), Valencia

46145

Kinder- und Jugendaerztliche Gemeinschaftspraxis ( Site 0077), Oberhausen

46183

Centro de Salud Eliana ( Site 0114), Valencia

46200

Centro de Salud Paiporta ( Site 0117), Paiporta

46930

C.S. Quart de Poblet ( Site 0115), Quart de Poblet

49565

Kinderarztpraxis ( Site 0061), Bramsche

50160

Kliiniliste Uuringute Keskus OU ( Site 0161), Tartu

50354

Kinderpraxis Dr. med. Andreas Petri ( Site 0066), Hürth

52146

Kinderarztpraxis ( Site 0063), Würselen

63739

NETSTAP - Sandner ( Site 0072), Aschaffenburg

72713

Vee Perearstikeskus ( Site 0163), Paide

76863

Kinderarztpraxis Dr. Juenger ( Site 0073), Herxheim

76889

Praxis Dr. Siegfried Simmet ( Site 0069), Schweigen

83471

Praxiszentrum Triftplatz ( Site 0075), Schönau

97941

Kinderarztpraxis Dr. Rolf Ebert & Dr. Matthias Huebener ( Site 0062), Tauberbischofsheim

99086

Praxis fur Kinder und Jugendmedizin Eivy Franke Beckmann ( Site 0064), Erfurt

119333

Central Clinical Hospital of Russian Academy Science ( Site 0052), Moscow

193312

Children s City Polyclinic No. 45 of the Nevsky District ( Site 0048), Saint Petersburg

620034

MAI Childrens City Clinical Hospital 11 ( Site 0047), Yekaterinburg

377 01

MUDr. Daniel Drazan - Prakticky lekar pro deti a dorost ( Site 0151), Jindřichův Hradec

276 01

MU Dr. Jan Nemecek - Prakticky lekar pro deti a dorost ( Site 0152), Mělník

257 41

MUDr. Josef Zemanek ( Site 0153), Týnec nad Sázavou

115 27

Pan and Aglaia Kyriakou Children s Hospital ( Site 0183), Athens

University of Athens - Aghia Sophia Childrens Hospital ( Site 0185), Athens

124 62

Attikon University General Hospital of Athens ( Site 0182), Athens

411 10

University General Hospital of Larissa ( Site 0184), Larissa

546 42

Hippokration General Hospital of Thessaloniki ( Site 0181), Thessaloniki

85-796

Centrum Medyczne Pratia Bydgoszcz ( Site 0086), Bydgoszcz

39-200

Prywatny Gabinet Lekarski Dr med Jerzy Brzostek ( Site 0084), Dębica

31-202

Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0085), Krakow

91-347

Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0092), Lodz

61-709

SPZOZ Szpital Dzieciecy Poznan ( Site 0089), Poznan

41-103

NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0087), Siemianowice Śląskie

55-100

Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 0083), Trzebnica

50-368

Uniwersytecki Szpital Kliniczny ( Site 0093), Wroclaw

05-092

SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0091), Łomianki

08916

Hospital Universitari Germans Trias i Pujol ( Site 0102), Badalona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04031846 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) | Biotech Hunter | Biotech Hunter