Clinical trial NCT01457495: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Diphtheria
Haemophilus Influenzae Type b (Hib)
Poliomyelitis
Pertussis
Tetanus
Keywords: Infants
combined vaccine
DTPa-HBV-IPV/Hib
DTPa-IPV/Hib
safety
Immunogenicity
HBV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 312
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of subjects with antibody titers equal to or greater than cut-off value.
timeFrame: One month after the 2nd dose of the primary vaccination course (month 3)
Secondary outcomes:
measure: Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects
timeFrame: 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)
measure: Immunogenicity with respect to components of the study vaccines in terms of antibody titers
timeFrame: 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)
measure: Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response
timeFrame: One month after the 3rd dose of the primary vaccination course (Month 9)
measure: Occurrence of solicited local symptoms
timeFrame: Within 4 days after each vaccination and overall
measure: Occurrence of solicited general symptoms
timeFrame: Within 4 days after each vaccination and overall
measure: Occurrence of unsolicited symptoms
timeFrame: Within 30 days after each vaccination, and overall
measure: Occurrence of serious AEs
timeFrame: Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: