Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

PHASE3CompletedINTERVENTIONAL
Enrollment

694

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

December 1, 2021

Study Completion Date

December 1, 2021

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

V114

15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.

BIOLOGICAL

PCV13

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

Trial Locations (45)

486-0836

Morinaga Maternity Clinic ( Site 3345), Kasugai

457-8511

Social Medical Corporation Koujunkai Daido Clinic ( Site 3326), Nagoya

274-0063

Kyoritsu Narashinodai Hospital ( Site 3332), Funabashi

299-4503

Sotobo Children's Clinic ( Site 3323), Isumi

816-0801

Yokoyama Children's Clinic ( Site 3309), Kasuga

737-0193

Chugoku Rosai Hospital ( Site 3340), Kure

300-0028

Tsuchiura Kyodo General Hospital ( Site 3327), Tsuchiura

899-2503

Kagoshima Children's Hospital ( Site 3342), Hioki

210-0013

Kawasaki Municipal Hospital ( Site 3302), Kawasaki

252-0392

National Hospital Organization Sagamihara National Hospital ( Site 3303), Sagamihara

222-0036

JOHAS Yokohama Rosai Hospital ( Site 3343), Yokohama

514-1101

National Hospital Organization Mie Chuo Medical Center ( Site 3308), Tsu

983-8520

National Hospital Organization Sendai Medical Center ( Site 3311), Sendai

396-8555

Ina Central Hospital ( Site 3346), Ina

390-8510

Aizawa Hospital ( Site 3313), Matsumoto

598-0043

Taniguchi Hospital ( Site 3310), Izumisano

591-8023

Medical corporation Waffle GunGunkids Clinic ( Site 3329), Sakai

564-8567

Suita Municipal Hospital ( Site 3338), Suita

569-1192

Takatsuki General Hospital ( Site 3318), Takatsuki

350-0001

Aiwa Hospital ( Site 3336), Kawagoe

332-8558

Saiseikai Kawaguchi General Hospital ( Site 3304), Kawaguchi

359-1141

Hara Children's Clinic ( Site 3339), Tokorozawa

351-0102

National Hospital Organization Saitama Hospital ( Site 3312), Wako

520-3046

Saiseikai Shiga Hospital ( Site 3349), Rittō

426-0067

Kobayashi Pediatric Clinic ( Site 3301), Fujieda

190-0002

Saiwai Kodomo Clinic ( Site 3331), Tachikawa

206-0025

Nishida Kodomo Clinic ( Site 3306), Tama

910-0833

Fukui Aiiku Hospital ( Site 3315), Fukui

918-8503

Fukui-ken Saiseikai Hospital ( Site 3314), Fukui

814-0121

Shindo Children's Clinic ( Site 3325), Fukuoka

815-0033

Kurokawa Michiko Pediatric Clinic ( Site 3319), Fukuoka

819-0002

Shimomura Pediatrics Clinic ( Site 3320), Fukuoka

819-0041

INAMITSU Children's Clinic ( Site 3321), Fukuoka

862-0920

Nagamine Soyokaze Clinic ( Site 3348), Kumamoto

388-8004

Minaminagano Medical Center Shinonoi General Hospital ( Site 3344), Nagano

536-0001

Saiseikai Noe Hospital ( Site 3330), Osaka

544-0033

Kubota Children's Clinic ( Site 3334), Osaka

553-0001

Sano Kids Clinic ( Site 3341), Osaka

556-0005

Aizenbashi Hospital ( Site 3317), Osaka

420-0853

Japanese Red Cross Shizuoka Hospital ( Site 3322), Shizuoka

424-8636

Shizuoka City Shimizu Hospital ( Site 3347), Shizuoka

112-0001

Hosaka Children's Clinic ( Site 3307), Tokyo

130-8587

The Fraternity Memorial Hospital ( Site 3333), Tokyo

146-0095

Okawa Children & Family Clinic ( Site 3305), Tokyo

939-8511

Toyama City Hospital ( Site 3328), Toyama

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04384107 - Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033) | Biotech Hunter | Biotech Hunter