Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

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 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, , 

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