Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00317135

Purpose

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

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 Fever Hepatitis Hepatitis B Tetanus Whooping Cough

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Mths Age), After a Hepatitis B Birth Dose

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Day 0-3 after each dose, fever >38.5°C(axillary).

Secondary Outcome Measures:

Solicited events other than fever (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study).

Estimated Enrollment:	500
Study Start Date:	December 2003

Detailed Description:

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™

Eligibility

Ages Eligible for Study:	up to 3 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria at study entry:

Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria at study entry:

Any confirmed immunodeficient condition, based on medical history & 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.
Acute disease at the time of enrolment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317135

Locations

Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	759346/004
Study First Received:	February 15, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00317135
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

Meningitis
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