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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.

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ClinicalTrials.gov Identifier: NCT00317187
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : October 3, 2011
Sponsor:
Information provided by:
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Hib Disease Hepatitis B Diphtheria Pertussis Neisseria Meningitidis Serogroup Diseases Tetanus Biological: DTPw-HBV/Hib-MenAC conjugate vaccine Phase 3

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™

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Start Date : June 2004





Primary Outcome Measures :
  1. Day 0-3 after each dose, fever >38.5°C(axillary).

Secondary Outcome Measures :
  1. Solicited events other than fever (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study).


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Ages Eligible for Study:   56 Days to 83 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317187


Locations
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00317187     History of Changes
Other Study ID Numbers: 100791
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Diphtheria
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs