Brief Title
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
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
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of subjects with antibody titers equal to or greater than cut-off value.
Secondary Outcome
Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects
Condition
Hepatitis B
Intervention
DTPa-HBV-IPV/Hib (Infanrix-hexa™)
Study Arms / Comparison Groups
DTPa 1 Group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
312
Start Date
September 1998
Completion Date
September 1999
Primary Completion Date
September 1999
Eligibility Criteria
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.
Gender
All
Ages
12 Weeks - 16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
GSK Clinical Trials, ,
Administrative Informations
NCT ID
NCT01457495
Organization ID
217744/031
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
June 2017