Who is sponsoring NCT00317122?

NCT00317122 is sponsored by GlaxoSmithKline.

What condition does NCT00317122 study?

NCT00317122 studies Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis.

What drugs are being tested in NCT00317122?

Interventions: DTPw-HBV/Hib-MenAC conjugate vaccine.

What is the status of NCT00317122?

NCT00317122 is currently COMPLETED.

Last reviewed 2016-09-20 · How we verify

Demonstrate Non-inferiority of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ With Respect to Anti-HBs Immune Response, When Given to Healthy Infants at 6,10 & 14 Weeks Age, After a Birth Dose of Hepatitis B Vaccine

NCT00317122 Phase 3 COMPLETED

This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	192
Start date	2004-10
Completion	2005-07

Conditions

Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Interventions

DTPw-HBV/Hib-MenAC conjugate vaccine

Primary outcomes

One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.

Countries

South Africa