Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old

PHASE2CompletedINTERVENTIONAL
Enrollment

461

Participants

Timeline

Start Date

March 24, 2005

Primary Completion Date

March 1, 2006

Study Completion Date

March 3, 2006

Conditions
Infections, Meningococcal
Interventions
BIOLOGICAL

Conjugated meningococcal ACWY-TT (vaccine)

One intramuscular dose during the primary vaccination

BIOLOGICAL

DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

BIOLOGICAL

DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

BIOLOGICAL

Meningitec™

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

BIOLOGICAL

Mencevax™ACWY

One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)

Trial Locations (17)

11527

GSK Investigational Site, Athens

19003

GSK Investigational Site, Markopoulo Mesogaias

19005

GSK Investigational Site, Nea Makri

22100

GSK Investigational Site, Tripoli

26500

GSK Investigational Site, Rio/Patras

54636

GSK Investigational Site, Thessaloniki

69100

GSK Investigational Site, Komotini

71110

GSK Investigational Site, Heraklion, Crete

A-4070

GSK Investigational Site, Eferding

A-8036

GSK Investigational Site, Graz

A-5020

GSK Investigational Site, Salzburg

A-1020

GSK Investigational Site, Vienna

A-9500

GSK Investigational Site, Villach

A-4600

GSK Investigational Site, Wels

452 21

GSK Investigational Site, Ioannina

571 00

GSK Investigational Site, Koufalia

564 29

GSK Investigational Site, N. Efkarpia, Thessaloniki

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00196976 - Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old | Biotech Hunter | Biotech Hunter