Status:
COMPLETED
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a thr...
Eligibility Criteria
Inclusion
- Inclusion criteria for enrolment at birth
- Written informed consent obtained from the parents or guardians of the subject.
- A male or female infant born after a normal gestation period (between 36 and 42 weeks).
- Born to a mother seronegative for HBsAg.
- Free of obvious health problems as established by clinical examination before entering into the study.
- Inclusion criteria for administration of the combined vaccine regimen
- Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study.
- Inclusion criteria for administration of the booster dose
- Between, and including, 15 and 18 months of age at the time of the booster vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Completion of the three-dose primary vaccination course.
Exclusion
- Exclusion criteria for enrolment at birth
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- Major congenital defect(s).
- Exclusion criteria for administration of the combined vaccine regimen
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Exclusion criteria for administration of the booster dose
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination.
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period.
- Hypersensitivity reaction due to vaccine in primary course
- Encephalopathy within 7 days of previous vaccination with DTP vaccine
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00880477
Start Date
January 1 2001
End Date
November 1 2002
Last Update
September 7 2016
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