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.
Information provided by:
GlaxoSmithKline Identifier:
First received: February 15, 2006
Last updated: September 29, 2011
Last verified: September 2011
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
Hib Disease
Hepatitis B
Neisseria Meningitidis Serogroup Diseases
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:

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™


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00317135

GSK Investigational Site
Muntinlupa, Philippines, 1781
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00317135     History of Changes
Other Study ID Numbers: 759346/004
Study First Received: February 15, 2006
Last Updated: September 29, 2011
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 30, 2015