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
  Purpose

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.


Condition Intervention Phase
Hib Disease
Hepatitis B
Diphtheria
Pertussis
Neisseria Meningitidis Serogroup Diseases
Tetanus
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.

Secondary Outcome Measures:
  • "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)"

Estimated Enrollment: 192
Study Start Date: October 2004
Intervention Details:
    Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
    Other Name: DTPw-HBV/Hib-MenAC conjugate vaccine
Detailed Description:

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

  • GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
  • GSK Biologicals' Tritanrix™-HepB/Hiberix™
  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317122

Locations
South Africa
GSK Investigational Site
Brits, South Africa
GSK Investigational Site
Centurion, South Africa
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00317122     History of Changes
Other Study ID Numbers: 759346/007
Study First Received: February 23, 2006
Last Updated: September 29, 2011
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 22, 2014