Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,191

Participants

Timeline

Start Date

August 28, 2019

Primary Completion Date

October 29, 2021

Study Completion Date

October 29, 2021

Conditions
Pneumococcal Infections
Interventions
DRUG

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.

DRUG

Prevenar 13™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.

DRUG

Vaxelis™

Intramuscular 0.5 mL single dose

DRUG

M-M-R®II

Subcutaneous 0.5 mL single dose

DRUG

VARIVAX™

Subcutaneous 0.5 mL single dose

Trial Locations (24)

2650

Hvidovre Hospital ( Site 0003), Hvidovre

3103

Sykehuset i Vestfold ( Site 0063), Tønsberg

4011

Stavanger universitetssykehus ( Site 0062), Stavanger

5000

Odense Universitetshospital ( Site 0001), Odense C

7400

Regionshospitalet Herning Hospitalsenheden Vest ( Site 0006), Herning

8200

Aarhus Universitetshosp. Skejby ( Site 0002), Aarhus

9000

Aalborg Universitetshospital ( Site 0005), Aalborg

9800

Sygehus Vendsyssel Hjoerring ( Site 0004), Hjørring

16132

IRCCS Ospedale Policlinico San Martino ( Site 0042), Genova

20520

Turun rokotetutkimuskeskus ( Site 0026), Turku

28100

Porin rokotetutkimusklinikka ( Site 0027), Pori

33100

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0021), Tampere

60100

Seinajoki Vaccine Research Center ( Site 0028), Seinäjoki

67100

Kokkolan rokotetutkimusklinikka ( Site 0029), Kokkola

70124

A.O. Policlinico Consorziale di Bari ( Site 0044), Bari

71121

A.O.U. Riuniti Di Foggia - Igiene Universitaria ( Site 0046), Foggia

90220

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0030), Oulu

02230

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0024), Espoo

00100

Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0022), Helsinki

00930

Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0023), Helsinki

04400

Jarvenpaan rokotetutkimuskeskus ( Site 0025), Järvenpää

00168

Policlinico Universitario Agostino Gemelli ( Site 0048), Rome

0450

Oslo Universitetssykehus HF Ulleval Sykehus ( Site 0061), Oslo

901 85

Norrlands Universitetssjukhus ( Site 0100), Umeå

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04016714 - Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026) | Biotech Hunter | Biotech Hunter