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:	NCT00317187

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:	Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants 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:	June 2004

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:	56 Days to 83 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

• Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.

Exclusion criteria:

Any confirmed immunodeficient condition, based on medical history and physical examination.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317187

Locations

Thailand
GSK Investigational Site
Bangkok, Thailand, 10400

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications indexed to this study:

Kerdpanich A, Warachit B, Kosuwon P, Gatchalian SR, Watanaveeradej V, Borkird T, Kosalaraksa P, Han HH, Hutagalung Y, Boutriau D, Dobbelaere K. Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated. Int J Infect Dis. 2008 Jan;12(1):88-97. Epub 2007 Aug 22.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100791
Study First Received:	February 17, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00317187
Health Authority:	Thailand: Ministry of Public Health

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