A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,515

Participants

Timeline

Start Date

July 16, 2018

Primary Completion Date

January 20, 2020

Study Completion Date

January 20, 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 Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

BIOLOGICAL

Prevnar 13™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose

BIOLOGICAL

PNEUMOVAX™23

23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Trial Locations (78)

1010

Auckland Clinical Studies Limited ( Site 0189), Auckland

Optimal Clinical Trials ( Site 0182), Auckland

2010

Holdsworth House Medical Practice ( Site 0170), Sydney

2148

Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174), Blacktown

2259

Paratus Clinical Kanwal ( Site 0172), Kanwal

2747

Nepean Hospital ( Site 0176), Kingswood

3010

Lakeland Clinical Trials ( Site 0181), Rotorua

3124

Emeritus Research Pty Ltd ( Site 0173), Camberwell

3143

Bay of Plenty Clinical School ( Site 0186), Tauranga

4064

Core Research Group Pty limited ( Site 0175), Brisbane

6021

P3 Research Ltd - Wellington ( Site 0184), Wellington

8011

Christchurch Heart Institute ( Site 0280), Christchurch

8013

Southern Clinical Trials Ltd ( Site 0180), Christchurch

12553

Mid Hudson Medical Research ( Site 0022), New Windsor

14830

Corning Center For Clinical Research ( Site 0036), Corning

18102

Lehigh Valley Health Network ( Site 0040), Allentown

19104

University of Pennsylvania ( Site 0030), Philadelphia

27612

Wake Research Associates, LLC ( Site 0016), Raleigh

29651

Mountain View Clinical Research ( Site 0007), Greer

30303

Emory University School of Medicine at Grady Hospital ( Site 0027), Atlanta

33012

Indago Research & Health Center, Inc ( Site 0054), Hialeah

33189

Top Medical Research, Inc ( Site 0033), Cutler Bay

33407

Triple O Research Institute, P.A. ( Site 0026), West Palm Beach

34471

Renstar Medical Research ( Site 0008), Ocala

37660

Holston Medical Group ( Site 0025), Kingsport

47374

Reid Physician Associates ( Site 0055), Richmond

54449

Marshfield Clinic ( Site 0013), Marshfield

54601

Gundersen Health System ( Site 0021), La Crosse

60201

Evanston Premier Healthcare & Research, LLC. ( Site 0012), Evanston

60805

Pharmakon Inc ( Site 0049), Evergreen Park

64114

The Center for Pharmaceutical Research PC ( Site 0050), Kansas City

75024

Village Health Partners ( Site 0006), Plano

75071

Texas Institute Of Cardiology ( Site 0048), McKinney

76104

AIM Trials ( Site 0060), Fort Worth

77094

Private Practice Leadership, LLC ( Site 0051), Houston

77801

Texas Center For Drug Development ( Site 0041), Houston

83814

Kootenai Health ( Site 0042), Coeur d'Alene

84095

Copperview Medical Center ( Site 0038), South Jordan

85020

Central Phoenix Medical Clinic, LLC ( Site 0031), Phoenix

85306

Pulmonary Associates, PA ( Site 0043), Glendale

85941

Whiteriver Center for American Indian Health ( Site 0005), Whiteriver

86503

Chinle Comprehensive Health Care Facility ( Site 0001), Chinle

86504

Fort Defiance Center for American Indian Health ( Site 0002), Fort Defiance

87301

Gallup Center for American Indian Health ( Site 0003), Gallup

87420

Shiprock Center for American Indian Health ( Site 0004), Shiprock

89119

Clinical Research Consortium ( Site 0053), Las Vegas

92377

Inland Empire Clinical Trials, LLC ( Site 0052), Rialto

99216

Pulmonary & Sleep Research ( Site 0046), Spokane Valley

214019

Smolensk State Medical University ( Site 0246), Smolensk

410054

Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144), Saratov

420140

Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249), Kazan'

4781151

Hospital Dr. Hernan Henriquez Aravena ( Site 0105), Temuco

7560994

Clinica Arauco Salud ( Site 0100), Santiago

8330034

Centro de Investigacion Clinica UC CICUC ( Site 0104), Santiago

8330336

CECIM ( Site 0101), Santiago

9351603

CESFAM Esmeralda ( Site 0102), Santiago

08302

Internal Medicine Associates [Bridgeton, NJ] ( Site 0015), Bridgeton

77555-1115

University of Texas Medical Branch at Galveston ( Site 0034), Galveston

05403

Timber Lane Allergy & Asthma Research, LLC ( Site 0044), South Burlington

V5Z 1H2

The Liver and Intestinal Research Centre (LAIR) ( Site 0302), Vancouver

E1G 1A7

GA Research Associates, Ltd/Ltee ( Site 0303), Moncton

B2N 1L2

Colchester Research Group ( Site 0094), Truro

L8M 1K7

Hamilton Medical Research Group ( Site 0092), Hamilton

L3Y 5G8

SKDS Research Inc. ( Site 0099), Newmarket

J7J 2K8

Omnispec Recherche Clinique Inc ( Site 0093), Mirabel

H9R 3J1

Dynamik Research ( Site 0095), Pointe-Claire

G1N 4V3

Diex Recherche Quebec Inc ( Site 0091), Québec

J1J 2G2

Q & T Research Sherbrooke Inc. ( Site 0097), Sherbrooke

0626

Southern Clinical Trials - Waitemata ( Site 0183), Auckland

85-030

WSOZ im.T.Browicza w Bydgoszczy ( Site 0317), Bydgoszcz

85-796

Centrum Medyczne Pratia Bydgoszcz ( Site 0139), Bydgoszcz

80-382

Synexus Polska Sp. z o.o. ( Site 0238), Gdansk

30-033

Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233), Krakow

41-400

ID Clinic ( Site 0235), Mysłowice

96-100

Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319), Skierniewice

81-717

Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314), Sopot

50-136

Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236), Wroclaw

50-381

Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234), Wroclaw

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03547167 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY) | Biotech Hunter | Biotech Hunter