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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00317135
First received: February 15, 2006
Last updated: September 29, 2011
Last verified: September 2011
History of Changes

February 15, 2006
September 29, 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Hib Disease
  • Hepatitis B
  • Diphtheria
  • Pertussis
  • Neisseria Meningitidis Serogroup Diseases
  • Tetanus
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
Other Name: 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
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.
Both
up to 3 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00317135
759346/004
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