A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children

PHASE3CompletedINTERVENTIONAL
Enrollment

1,886

Participants

Timeline

Start Date

August 18, 2014

Primary Completion Date

April 18, 2015

Study Completion Date

April 18, 2015

Conditions
Influenza
Interventions
BIOLOGICAL

Influsplit Tetra™ vaccine produced by investigational process (IP)

Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.

BIOLOGICAL

Influsplit Tetra™ vaccine produced by licensed process (LP)

Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.

Trial Locations (53)

1000

GSK Investigational Site, Dhaka

1600

GSK Investigational Site, Prague

13055

GSK Investigational Site, Berlin

13100

GSK Investigational Site, Aix-en-Provence

14609

GSK Investigational Site, Rochester

15706

GSK Investigational Site, Santiago de Compostela

24534

GSK Investigational Site, Neumünster

24937

GSK Investigational Site, Flensburg

25070

GSK Investigational Site, Odolena Voda

28050

GSK Investigational Site, Madrid

29200

GSK Investigational Site, Antequera/Málaga

32584

GSK Investigational Site, Löhne

32756

GSK Investigational Site, Detmold

37203

GSK Investigational Site, Nashville

37701

GSK Investigational Site, Jindřichův Hradec

40100

GSK Investigational Site, Dax

41014

GSK Investigational Site, Seville

44277

GSK Investigational Site, Nantes

45355

GSK Investigational Site, Essen

45359

GSK Investigational Site, Essen

47533

GSK Investigational Site, Kleve-Materborn

47574

GSK Investigational Site, Goch

50351

GSK Investigational Site, Chlumec nad Cidlinou

54270

GSK Investigational Site, Essey-lès-Nancy

54290

GSK Investigational Site, Trier

67207

GSK Investigational Site, Wichita

70469

GSK Investigational Site, Stuttgart

70800

GSK Investigational Site, Ostrava - Poruba

75131

GSK Investigational Site, Lipník nad Bečvou

76620

GSK Investigational Site, Le Havre

77694

GSK Investigational Site, Kehl

83300

GSK Investigational Site, Draguignan

83471

GSK Investigational Site, Schönau am Königssee

85551

GSK Investigational Site, Kirchheim

97070

GSK Investigational Site, Würzburg

02886

GSK Investigational Site, Warwick

613 00

GSK Investigational Site, Brno

405 01

GSK Investigational Site, Děčín

Unknown

GSK Investigational Site, Liberec

547 01

GSK Investigational Site, Náchod

532 03

GSK Investigational Site, Pardubice

06300

GSK Investigational Site, Nice

04178

GSK Investigational Site, Leipzig

01445

GSK Investigational Site, Radebeul

04808

GSK Investigational Site, Wurzen

85-168

GSK Investigational Site, Bydgoszcz

39-200

GSK Investigational Site, Dębica

40-018

GSK Investigational Site, Katowice

62-064

GSK Investigational Site, Poznan

41-103

GSK Investigational Site, Siemianowice Śląskie

54-019

GSK Investigational Site, Wroclaw

08916

GSK Investigational Site, Badalona

09006

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02207413 - A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children | Biotech Hunter | Biotech Hunter