NCT00126984View on ClinicalTrials.gov

Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Infections, Meningococcal
Interventions
BIOLOGICAL

Conjugated meningococcal ACWY-TT (vaccine)

One intramuscular dose during the primary vaccination

BIOLOGICAL

DTPa/Hib containing vaccine

One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

BIOLOGICAL

Meningitec

One intramuscular dose during the primary vaccination study in subjects of 12-14 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 subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)

Trial Locations (42)

10315

GSK Investigational Site, Berlin

10967

GSK Investigational Site, Berlin

10999

GSK Investigational Site, Berlin

12627

GSK Investigational Site, Berlin

12679

GSK Investigational Site, Berlin

13055

GSK Investigational Site, Berlin

13355

GSK Investigational Site, Berlin

14197

GSK Investigational Site, Berlin

54294

GSK Investigational Site, Trier

54568

GSK Investigational Site, Gerolstein

55131

GSK Investigational Site, Mainz

55294

GSK Investigational Site, Bodenheim

67059

GSK Investigational Site, Ludwigshafen am Rhein

67547

GSK Investigational Site, Worms

68309

GSK Investigational Site, Mannheim

69214

GSK Investigational Site, Eppelheim

71634

GSK Investigational Site, Ludwigsburg

71720

GSK Investigational Site, Oberstenfeld

74321

GSK Investigational Site, Bietigheim-Bissingen

75015

GSK Investigational Site, Bretten

80939

GSK Investigational Site, Munich

81675

GSK Investigational Site, Munich

81735

GSK Investigational Site, Munich

82140

GSK Investigational Site, Olching

82327

GSK Investigational Site, Tutzing

82362

GSK Investigational Site, Weilheim

83684

GSK Investigational Site, Tegernsee

86399

GSK Investigational Site, Bobingen

86720

GSK Investigational Site, Nördlingen

90473

GSK Investigational Site, Nuremberg

95463

GSK Investigational Site, Bindlach

99425

GSK Investigational Site, Weimar

A-7540

GSK Investigational Site, Güssing

A 2491

GSK Investigational Site, Neufeld/Leitha

A-5020

GSK Investigational Site, Salzburg

A-9500

GSK Investigational Site, Villach

A-4600

GSK Investigational Site, Wels

04720

GSK Investigational Site, Döbeln

01169

GSK Investigational Site, Dresden

04178

GSK Investigational Site, Leipzig

09366

GSK Investigational Site, Stollberg

07356

GSK Investigational Site, Bad Lobenstein

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY