Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women

PHASE4CompletedINTERVENTIONAL
Enrollment

688

Participants

Timeline

Start Date

October 14, 2015

Primary Completion Date

August 14, 2017

Study Completion Date

October 24, 2017

Conditions
Diphtheria-Tetanus-acellular Pertussis Vaccines
Interventions
BIOLOGICAL

Boostrix™

One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.

DRUG

Saline placebo

One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.

Trial Locations (35)

3052

GSK Investigational Site, Parkville

3053

GSK Investigational Site, Carlton

3065

GSK Investigational Site, Fitzroy

10126

GSK Investigational Site, Turin

14059

GSK Investigational Site, Prague

14700

GSK Investigational Site, Prague

15706

GSK Investigational Site, Santiago de Compostela

20122

GSK Investigational Site, Milan

20142

GSK Investigational Site, Milan

20154

GSK Investigational Site, Milan

20520

GSK Investigational Site, Turku

28023

GSK Investigational Site, Aravaca

28040

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Novara

28222

GSK Investigational Site, Majadahonda (Madrid)

28660

GSK Investigational Site, Boadilla del Monte

28938

GSK Investigational Site, Móstoles

29004

GSK Investigational Site, Málaga

29200

GSK Investigational Site, Antequera/Málaga

33100

GSK Investigational Site, Tampere

41013

GSK Investigational Site, Seville

41940

GSK Investigational Site, Seville

60100

GSK Investigational Site, Seinäjoki

67100

GSK Investigational Site, Kokkola

90220

GSK Investigational Site, Oulu

T3B 6A8

GSK Investigational Site, Calgary

B3K 6R8

GSK Investigational Site, Halifax

P3A 1W8

GSK Investigational Site, Greater Sudbury

H3T 1C5

GSK Investigational Site, Montreal

H3P 3W3

GSK Investigational Site, Mount Royal

613 00

GSK Investigational Site, Brno

500 02

GSK Investigational Site, Hradec Králové

703 84

GSK Investigational Site, Ostrava - Vitkovice

09006

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02377349 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women | Biotech Hunter | Biotech Hunter