A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy

PHASE4CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

August 23, 2016

Primary Completion Date

July 5, 2017

Study Completion Date

July 5, 2017

Conditions
Hepatitis B
Interventions
BIOLOGICAL

Engerix-B Kinder

Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.

Trial Locations (14)

13055

GSK Investigational Site, Berlin

24534

GSK Investigational Site, Neumünster

41236

GSK Investigational Site, Mönchengladbach

47574

GSK Investigational Site, Goch

49565

GSK Investigational Site, Bramsche

67227

GSK Investigational Site, Frankenthal

68161

GSK Investigational Site, Mannheim

70499

GSK Investigational Site, Stuttgart

77694

GSK Investigational Site, Kehl

78532

GSK Investigational Site, Tuttlingen

93413

GSK Investigational Site, Cham

95463

GSK Investigational Site, Bindlach

97070

GSK Investigational Site, Würzburg

04808

GSK Investigational Site, Wurzen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02798952 - A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy | Biotech Hunter | Biotech Hunter