Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

PHASE3CompletedINTERVENTIONAL
Enrollment

4,538

Participants

Timeline

Start Date

October 10, 2012

Primary Completion Date

February 3, 2015

Study Completion Date

August 18, 2015

Conditions
MeaslesMumpsRubellaMeasles-Mumps-Rubella Vaccine
Interventions
BIOLOGICAL

Priorix

Subjects receive one dose of either minimum (Inv\_MMR\_Min) or medium (Inv\_MMR\_Med) potency lot at Day 0 and a dose of separate potency lot (Inv\_MMR\_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.

BIOLOGICAL

M-M-R II

Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.

BIOLOGICAL

Varivax

Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.

BIOLOGICAL

Havrix

Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.

BIOLOGICAL

Prevnar 13

US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.

Trial Locations (81)

1600

GSK Investigational Site, Prague

10330

GSK Investigational Site, Bangkok

10400

GSK Investigational Site, Bangkok

10700

GSK Investigational Site, Bangkok

12120

GSK Investigational Site, Pathum Thani

15706

GSK Investigational Site, Santiago de Compostela

15904

GSK Investigational Site, Johnstown

20400

GSK Investigational Site, Kuala Terengganu

20520

GSK Investigational Site, Turku

21201

GSK Investigational Site, Baltimore

21401

GSK Investigational Site, Annapolis

21702

GSK Investigational Site, Frederick

23113

GSK Investigational Site, Midlothian

23223

GSK Investigational Site, Richmond

25070

GSK Investigational Site, Odolena Voda

28721

GSK Investigational Site, Clyde

29200

GSK Investigational Site, Antequera/Málaga

29406

GSK Investigational Site, Charleston

29414

GSK Investigational Site, Charleston

32701

GSK Investigational Site, Altamonte Springs

33014

GSK Investigational Site, Miami Lakes

33100

GSK Investigational Site, Tampere

33184

GSK Investigational Site, Miami

33606

GSK Investigational Site, Tampa

34102

GSK Investigational Site, Naples

35205

GSK Investigational Site, Birmingham

37701

GSK Investigational Site, Jindřichův Hradec

40207

GSK Investigational Site, Louisville

41014

GSK Investigational Site, Seville

43606

GSK Investigational Site, Toledo

44121

GSK Investigational Site, Cleveland

44514

GSK Investigational Site, Youngstown

45406

GSK Investigational Site, Dayton

45414

GSK Investigational Site, Dayton

46015

GSK Investigational Site, Liberec

46020

GSK Investigational Site, Valencia

46024

GSK Investigational Site, Valencia

46183

GSK Investigational Site, L'Eliana, Valencia

46200

GSK Investigational Site, Valencia

46930

GSK Investigational Site, Quart de Poblet, Valencia

47150

GSK Investigational Site, New Albany

50200

GSK Investigational Site, Chiang Mai

50265

GSK Investigational Site, West Des Moines

50351

GSK Investigational Site, Chlumec nad Cidlinou

64108

GSK Investigational Site, Kansas City

67205

GSK Investigational Site, Wichita

68131

GSK Investigational Site, Omaha

68504

GSK Investigational Site, Lincoln

68505

GSK Investigational Site, Lincoln

70800

GSK Investigational Site, Ostrava - Poruba

72205

GSK Investigational Site, Little Rock

72401

GSK Investigational Site, Jonesboro

75131

GSK Investigational Site, Lipník nad Bečvou

77087

GSK Investigational Site, Houston

84041

GSK Investigational Site, Layton

84663

GSK Investigational Site, Springville

84790

GSK Investigational Site, St. George

85012

GSK Investigational Site, Phoenix

85032

GSK Investigational Site, Phoenix

90220

GSK Investigational Site, Oulu

91790

GSK Investigational Site, West Covina

93586

GSK Investigational Site, Kuching

96000

GSK Investigational Site, Sibu

97030

GSK Investigational Site, Gresham

98926

GSK Investigational Site, Ellensburg

47304-5547

GSK Investigational Site, Muncie

256 01

GSK Investigational Site, Benešov

405 01

GSK Investigational Site, Děčín

272 01

GSK Investigational Site, Kladno

547 01

GSK Investigational Site, Náchod

532 03

GSK Investigational Site, Pardubice

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

00784

GSK Investigational Site, Guayama

00716

GSK Investigational Site, Ponce

00936-5067

GSK Investigational Site, San Juan

08042

GSK Investigational Site, Barcelona

08540

GSK Investigational Site, Centelles (Barcelona)

08560

GSK Investigational Site, Manlleu

08500

GSK Investigational Site, Vic

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01681992 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life | Biotech Hunter | Biotech Hunter