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Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00317122
First received: February 23, 2006
Last updated: September 29, 2011
Last verified: September 2011
History of Changes

February 23, 2006
September 29, 2011
October 2004
Not Provided
One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
Same as current
Complete list of historical versions of study NCT00317122 on ClinicalTrials.gov Archive Site
  • "Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens.
  • Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)"
Same as current
Not Provided
Not Provided
 
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
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 Wks Age, After a Birth Dose of Hepatitis B Vaccine

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.

Randomized study with two groups to receive one of the following vaccination regimens:

  • GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
  • GSK Biologicals' Tritanrix™-HepB/Hiberix™
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hib Disease
  • Hepatitis B
  • Diphtheria
  • Pertussis
  • Neisseria Meningitidis Serogroup Diseases
  • Tetanus
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
Other Name: DTPw-HBV/Hib-MenAC conjugate vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
Not Provided
Not Provided

Inclusion criteria:

  • Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV & HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria:

  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious illness.
  • Any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • A birth dose of hepatitis B vaccine given outside the frame of this study.
Both
up to 10 Days
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00317122
759346/007
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP