ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00317135
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : October 3, 2011
Sponsor:
Information provided by:
GlaxoSmithKline

February 15, 2006
April 24, 2006
October 3, 2011
December 2003
Not Provided
Day 0-3 after each dose, fever >38.5°C(axillary).
Same as current
Complete list of historical versions of study NCT00317135 on ClinicalTrials.gov Archive Site
Solicited events other than fever (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study).
Same as current
Not Provided
Not Provided
 
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
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
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™.

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™

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Hib Disease
  • Hepatitis B
  • Diphtheria
  • Pertussis
  • Neisseria Meningitidis Serogroup Diseases
  • Tetanus
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
Same as current
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
up to 3 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
 
NCT00317135
759346/004
Not Provided
Not Provided
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP