Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

709

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

November 30, 2006

Study Completion Date

November 30, 2006

Conditions
Neisseria MeningitidisHaemophilus Influenzae Type b
Interventions
BIOLOGICAL

Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

BIOLOGICAL

Infanrix Penta

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

BIOLOGICAL

Infanrix hexa

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

BIOLOGICAL

Neis-Vac-C

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Trial Locations (16)

15140

GSK Investigational Site, Lahti

20520

GSK Investigational Site, Turku

26900

GSK Investigational Site, Lodi

28120

GSK Investigational Site, Pori

33200

GSK Investigational Site, Tampere

48100

GSK Investigational Site, Kotka

70124

GSK Investigational Site, Bari

90100

GSK Investigational Site, Oulu

97100

GSK Investigational Site, Ragusa

02100

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

00930

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

01300

GSK Investigational Site, Vantaa

01600

GSK Investigational Site, Vantaa

07100

GSK Investigational Site, Sassari

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY