Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

PHASE4CompletedINTERVENTIONAL
Enrollment

601

Participants

Timeline

Start Date

January 22, 2016

Primary Completion Date

March 7, 2018

Study Completion Date

March 7, 2018

Conditions
Acellular PertussisTetanusPoliomyelitisDiphtheriaDiphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Interventions
BIOLOGICAL

Infanrix hexa

• All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh.

DRUG

Prevnar13

• All subjects will receive Infanrix hexa co-administered with Prevenar13\* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. \*In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh.

Trial Locations (30)

3053

GSK Investigational Site, Carlton

10126

GSK Investigational Site, Turin

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

28050

GSK Investigational Site, Madrid

28100

GSK Investigational Site, Novara

28222

GSK Investigational Site, Majadahonda (Madrid)

28938

GSK Investigational Site, Móstoles

29004

GSK Investigational Site, Málaga

29200

GSK Investigational Site, Antequera/Málaga

33100

GSK Investigational Site, Tampere

41014

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

H3T 1C5

GSK Investigational Site, Montreal

613 00

GSK Investigational Site, Brno

500 02

GSK Investigational Site, Hradec Králové

703 84

GSK Investigational Site, Ostrava - Vitkovice

140 59

GSK Investigational Site, Prague

09006

GSK Investigational Site, Burgos

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02422264 - Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery | Biotech Hunter | Biotech Hunter