Hepatitis B Clinical Trial
Official title:
Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites
Verified date | June 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.
Status | Completed |
Enrollment | 312 |
Est. completion date | September 1999 |
Est. primary completion date | September 1999 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Weeks to 16 Weeks |
Eligibility |
Inclusion Criteria: - A male or female between 12 and 16 weeks of age at the time of the first vaccination. - Free of obvious health problems as established by medical history and clinical examination before entering into the study. - Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure. Exclusion Criteria: - Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. - Administration of chronic immunosuppressants or immune-modifying drugs during the study period. - Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose. - Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases. - History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. - History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B. - Major congenital defects or serious chronic illness. - Progressive neurological disorders. - Administration of immunoglobulins and/or any blood products since birth and during the study period. - Acute febrile illness at the time of planned vaccination. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects with antibody titers equal to or greater than cut-off value. | One month after the 2nd dose of the primary vaccination course (month 3) | ||
Secondary | Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects | One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) | ||
Secondary | Immunogenicity with respect to components of the study vaccines in terms of antibody titers | One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) | ||
Secondary | Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response | One month after the 3rd dose of the primary vaccination course (Month 9) | ||
Secondary | Occurrence of solicited local symptoms | Within 4 days after each vaccination and overall | ||
Secondary | Occurrence of solicited general symptoms | Within 4 days after each vaccination and overall | ||
Secondary | Occurrence of unsolicited symptoms | Within 30 days after each vaccination, and overall | ||
Secondary | Occurrence of serious AEs | Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination |
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