Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00290303

Purpose

"The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 & 14 weeks age."

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Hib Diseases Neisseria Meningitidis Serogroups A & C 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 Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Show Non-Inferiority of Tritanrix™-HepB/Hib-MenAC (+/- Hepatitis B Vaccine at Birth) vs Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vacc. at Birth for Antibody Response to All Vaccine Antigens Given in Healthy Infants

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Immunogenicity: One month post-dose 3, measurement of serum bactericidal titers against meningococcal serogroups A & C (SBA-MenA; SBA-MenC), anti-PRP, anti-HBs & anti-diphtheria concentrations; & in some subjects anti-tetanus & anti-BPT concentrations.

Secondary Outcome Measures:

Reactogenicity and safety: After each vaccination, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)

Estimated Enrollment:	996
Study Start Date:	May 2004

Detailed Description:

"Randomized study with three groups (subjects born to mothers who do not carry hepatitis B virus) to receive one of the following vaccination regimens:

GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth
GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and no hepatitis B vaccine at birth - GSK Biologicals' Tritanrix™-HepB/Hiberix™

There will also be a fourth group (subjects born to mothers who do carry hepatitis B virus) to receive:

- GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth "

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Result of the maternal blood sample (presence/not of hepatitis B virus) is available.

Exclusion criteria:

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers).
Acute disease at the time of enrolment.
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
Hepatitis B vaccine given at birth outside the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290303

Locations

Philippines
GSK Clinical Trials Call Center
Manilla, Philippines

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Study ID Numbers:	100478
Study First Received:	February 10, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00290303
Health Authority:	Philippines: Bureau of Food and Drugs

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

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009