A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

PHASE3CompletedINTERVENTIONAL
Enrollment

2,409

Participants

Timeline

Start Date

December 14, 2018

Primary Completion Date

March 26, 2021

Study Completion Date

March 26, 2021

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

V114

V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

BIOLOGICAL

Prevnar 13™

Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose

Trial Locations (76)

333

Chang Gung Medical Foundation. Linkou ( Site 0098), Taoyuan District

407

Taichung Veterans General Hospital ( Site 0100), Taichung

3168

Monash Children s Hospital ( Site 0093), Clayton

5087

Children, Youth and Woman's Health Service ( Site 0094), North Adelaide

6009

Perth Children s Hospital ( Site 0092), Nedlands

10002

National Taiwan University Hospital ( Site 0097), Taipei

10330

Chulalongkorn University ( Site 0102), Bangkok

10491

Mackay Memorial Hospital ( Site 0099), Taipei

10700

Siriraj Hospital ( Site 0101), Bangkok

13011

Clinica Peruano Americana S.A. ( Site 0061), Trujillo

13057

Child Health Care Associates ( Site 0024), East Syracuse

15001

Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057), Lima

15416

Instituto de Investigacion Nutricional ( Site 0058), Lima

16148

CCP- Kid's Way ( Site 0008), Hermitage

16506

Allegheny Health & Wellness Pavilion West ( Site 0034), Erie

19107

Thomas Jefferson University ( Site 0029), Philadelphia

20520

Turun rokotetutkimuskeskus ( Site 0068), Turku

22415

Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085), Hamburg

28100

Porin Rokotetutkimusklinikka ( Site 0069), Pori

29407

Medical Research South, LLC ( Site 0013), Charleston

30450

Klinik Kesihatan Greentown ( Site 0132), Ipoh

32746

Children's Research, LLC ( Site 0025), Lake Mary

33100

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063), Tampere

34102

Advanced Research For Health Improvement LLC ( Site 0030), Naples

38448

Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083), Wolfsburg

40002

Srinagarind Hospital. Khon Kaen University ( Site 0104), Khon Kaen

40202

Novak Center for Childrens Health ( Site 0033), Louisville

41236

Kinderarztpraxis ( Site 0080), Mönchengladbach

Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091), Munchengladbach

42000

Klinik Kesihatan Pandamaran ( Site 0110), Port Klang

45419

Primedical Clinical Research ( Site 0035), Dayton

49565

Kinderarztpraxis ( Site 0123), Bramsche

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 0103), Chiang Mai

50354

Kinderarztpraxis ( Site 0081), Hürth

53792

University of Wisconsin American Family Children's Hospital ( Site 0023), Madison

59100

Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108), Kuala Lumpur

60100

Seinajoki Vaccine Research Center ( Site 0070), Seinäjoki

63739

Kinderarztpraxis ( Site 0124), Aschaffenburg

66213

Pediatric Partners, P.A. ( Site 0010), Overland Park

67100

Kokkolan rokotetutkimusklinikka ( Site 0071), Kokkola

70006

Medpharmics, LLC ( Site 0037), Metairie

74348

Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122), Lauffen am Neckar

77087

Pediatric Associates [Houston, TX] ( Site 0039), Houston

77573

University of Texas Medical Branch ( Site 0018), League City

83471

Kinderarztpraxis ( Site 0084), Schönau

84041

Tanner Clinic ( Site 0009), Layton

Wee Care Pediatrics ( Site 0031), Layton

84067

Wee Care Pediatrics ( Site 0020), Roy

90110

Prince of Songkla University, Faculty of Medicine ( Site 0105), Hat Yai

90220

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072), Oulu

90240

Premier Health Research Center, LLC ( Site 0005), Downey

92102

Khruz Biotechnology Research Institute ( Site 0006), San Diego

92647

Beach Pediatrics ( Site 0040), Huntington Beach

93586

Sarawak General Hospital ( Site 0107), Kuching

95051

Kaiser Permanente - Santa Clara ( Site 0027), Santa Clara

95119

Kaiser Permanente - San Jose ( Site 0036), San Jose

96000

Hospital Sibu ( Site 0111), Sibu

3109601

Rambam Medical Center ( Site 0076), Haifa

3515427

Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138), Haifa

3542129

Rambam Medical Center- Neve David Family Health Center ( Site 0139), Haifa

8410101

Soroka University Medical Center ( Site 0077), Beersheba

8471844

Soroka University Medical Center - Ramot Family health center ( Site 0078), Beersheba

8535700

Soroka University Medical Center - Rahat Family health center ( Site 0079), Rahat

8573000

Soroka Medical Center_ Hura Family health center ( Site 0137), Hura

T3B 6A8

Alberta Children s Hospital ( Site 0048), Calgary

V5Z 4H4

Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046), Vancouver

B3K 6R8

IWK Health Centre [Halifax, Canada] ( Site 0043), Halifax

P3A 1Y8

Medicor Research Inc. ( Site 0041), Greater Sudbury

L8M 1K7

Hamilton Medical Research Group ( Site 0049), Hamilton

H3T 1C5

CHU Sainte Justine ( Site 0047), Montreal

H9H 4Y6

McGill University Health Centre - Vaccine Study Centre ( Site 0045), Pierrefonds

G1E 7G9

CHUQ - Unite de Recherche en Sante Publique ( Site 0042), Québec

02230

Espoon rokotetutkimuskeskus ( Site 0066), Espoo

00100

Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064), Helsinki

00930

Ita-Helsingin Rokotetutkimuskeskus ( Site 0065), Helsinki

04400

Jarvenpaan rokotetutkimuskeskus ( Site 0067), Järvenpää

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03692871 - A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK) | Biotech Hunter | Biotech Hunter