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 - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00317122

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

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Tetanus Whooping Cough

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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

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

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

Locations

South Africa
GSK Investigational Site
Brits, South Africa
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208
GSK Investigational Site
Centurion, South Africa

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	759346/007
Study First Received:	February 23, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00317122
Health Authority:	South Africa: Medicines Control Council

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Cough
Neisseria meningitidis
Healthy
Diphtheria
Tetanus
Whooping cough

Gram-Negative Bacterial Infections
Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hepatitis B
DNA Virus Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009