Status:
COMPLETED
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Poliomyelitis
Eligibility:
All Genders
8-15 years
Phase:
PHASE4
Brief Summary
The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.
Eligibility Criteria
Inclusion
- A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a normal gestation period between 36 and 42 weeks.
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease.
- Planned administration of a vaccine not foreseen by the study protocol since birth and during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose of the three-dose primary vaccination course, with the exception of licensed Neisseria meningitides conjugate vaccines or Bacillus Calmette-Guérin (BCG) vaccine that can be given in between study visits or after the third visit, provided they are given preferably with a 4 weeks interval but not less than 3 weeks apart from the study vaccine doses.
- Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs since birth.
- Planned administration of immunoglobulins and/or any blood products since birth or planned administration during the period up to 30 days after the third dose of the primary vaccination course.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of seizures, progressive neurological disease or intra-cerebral haemorrhage.
- Major congenital defects or serious chronic illness.
- Acute febrile illness at the time of planned vaccination
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT01457547
Start Date
October 1 2003
End Date
May 1 2005
Last Update
August 5 2016
Active Locations (9)
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1
GSK Investigational Site
Helsinki, Finland, 00300
2
GSK Investigational Site
Bari, Apulia, Italy, 70124
3
GSK Investigational Site
Galatina (LE), Apulia, Italy, 73013
4
GSK Investigational Site
Maglie (LE), Apulia, Italy, 73024