Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)

PHASE1CompletedINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

April 2, 2019

Primary Completion Date

June 24, 2020

Study Completion Date

June 24, 2020

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine (PCV13)

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.

BIOLOGICAL

Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)

Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).

Trial Locations (14)

451-8511

Meitetsu Hospital ( Site 2805), Nagoya

299-4503

Sotobo Children's Clinic ( Site 2807), Isumi

818-0134

Hidaka Children's Clinic ( Site 2803), Dazaifu

372-0817

Isesaki Municipal Hospital ( Site 2806), Isesaki

210-0013

Kawasaki Municipal Hospital ( Site 2802), Kawasaki

238-8558

Yokosuka Kyosai Hospital ( Site 2804), Yokosuka

564-8567

Suita Municipal Hospital ( Site 2801), Suita

426-0067

Kobayashi Pediatric Clinic ( Site 2816), Fujieda

206-0025

Nishida Kodomo Clinic ( Site 2811), Tama

910-0833

Fukui Aiiku Hospital ( Site 2809), Fukui

918-8503

Fukui-ken Saiseikai Hospital ( Site 2813), Fukui

544-0033

Kubota Children's Clinic ( Site 2815), Osaka

420-0853

Japanese Red Cross Shizuoka Hospital ( Site 2817), Shizuoka

112-0001

Hosaka Children's Clinic ( Site 2814), Tokyo

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03848065 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028) | Biotech Hunter | Biotech Hunter