Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

PHASE3CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

February 13, 2023

Primary Completion Date

February 16, 2024

Study Completion Date

February 16, 2024

Conditions
Pneumococcal Infection
Interventions
BIOLOGICAL

V116

Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

BIOLOGICAL

Placebo

Saline in each 0.5 mL sterile solution

BIOLOGICAL

PCV15

Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension

BIOLOGICAL

PPSV23

Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Trial Locations (44)

2010

Holdsworth House Medical Practice ( Site 0402), Darlinghurst

3010

Pacific Clinical Research Network - Rotorua ( Site 0500), Rotorua

3110

P3 Research - Tauranga ( Site 0507), Tauranga

4029

Royal Brisbane and Women's Hospital ( Site 0400), Brisbane

5010

P3 Research - Lower Hutt ( Site 0508), Lower Hutt

6021

P3 Research - Wellington ( Site 0503), Wellington

8011

CGM Research Trust ( Site 0505), Christchurch

8013

Pacific Clinical Research Network - Forte ( Site 0501), Christchurch

12553

Mid Hudson Medical Research ( Site 0008), New Windsor

14068

Hallym University Sacred Heart Hospital ( Site 0303), Anyang-si

27713

EmVenio Research ( Site 0018), Fort Worth

33012

Indago Research & Health Center, Inc ( Site 0002), Hialeah

33407

Triple O Research Institute, P.A ( Site 0011), West Palm Beach

37660

Holston Medical Group ( Site 0010), Kingsport

39157

SKY Integrative Medical Center/SKYCRNG ( Site 0012), Ridgeland

85206

Aventiv Research ( Site 0022), Mesa

98801

Wenatchee Valley Hospital ( Site 0019), Wenatchee

3460000

Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010), Talca

4781151

Hospital Dr. Hernán Henríquez Aravena ( Site 1001), Temuco

7500000

Universidad San Sebastian - Providencia ( Site 1003), Providencia

7500692

Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008), Santiago

8330034

Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004), Santiago

8380420

Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006), Santiago

9340000

CESFAM Esmeralda ( Site 1009), Santiago

E1G 1A7

G A Research Associates ( Site 0100), Moncton

L8M 1K7

Hamilton Medical Research Group ( Site 0107), Hamilton

N5W 6A2

Milestone Research Inc. ( Site 0106), London

J7J 2K8

Manna Research Mirabel ( Site 0105), Mirabel

H2L 4E9

Clinique de médecine Urbaine du Quartier Latin ( Site 0111), Montreal

G9A 4P3

Diex Recherche Trois-Rivieres ( Site 0110), Trois-Rivières

G6P 6P6

Diex Recherche Victoriavile Inc. ( Site 0102), Victoriaville

830-0011

Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200), Kurume

750-0061

Shimonoseki Medical Center ( Site 0201), Shimonoseki

85-048

IN VIVO ( Site 0601), Bydgoszcz

85-796

Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607), Bydgoszcz

87-100

MICS Centrum Medyczne Torun ( Site 0606), Torun

35-055

Centrum Medyczne Medyk ( Site 0602), Rzeszów

40-081

Centrum Medyczne Pratia Katowice ( Site 0604), Katowice

40-156

Clinical Medical Research ( Site 0605), Katowice

96-100

Clinmedica Research Sp. z. o. o. ( Site 0603), Skierniewice

02841

Korea University Anam Hospital ( Site 0305), Seoul

03080

Seoul National University Hospital ( Site 0300), Seoul

05030

Konkuk University Medical Center ( Site 0302), Seoul

05355

Hallym University Kangdong Sacred Heart Hospital ( Site 0301), Seoul

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY