Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)

PHASE3CompletedINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

May 3, 2021

Study Completion Date

May 3, 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 Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.

BIOLOGICAL

Prevnar 13™

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

BIOLOGICAL

PNEUMOVAX™23

23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

Trial Locations (13)

1864

Perinatal HIV Research Unit ( Site 0042), Johannesburg

2001

Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043), Johannesburg

7505

Family Clinic Research With UBUNTU ( Site 0045), Cape Town

7626

Be Part Yoluntu Centre ( Site 0041), Paarl

10330

Chulalongkorn University-Pediatrics ( Site 0062), Bangkok

10700

Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064), Bangkok

21000

Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086), Vinnytsia

40002

Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063), Amphoe Mueang

49006

Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088), Dnipro

49115

Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082), Dnipro

50200

CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061), Chiang Mai

65014

Odesa Regional Center of Socially Significant Diseases ( Site 0083), Odesa

69063

Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089), Zaporizhzhya

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03921424 - Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED) | Biotech Hunter | Biotech Hunter