Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

Official Title
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Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months

Conditions
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Diphtheria, Poliomyelitis, Hepatitis B, Tetanus, Acellular Pertussis

Intervention / Treatment
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* Biological: Pediarix TM, Infanrix penta TM
* Biological: Hiberix TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A male or female infant between 6 and 8 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. Born after a normal gestation period (between 36 and 42 weeks). 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 other immune-modifying drugs since birth or planned administration during the study. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after. Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b. History of, or intercurrent, 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. Major congenital defects Serious chronic illness History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute disease at the time of enrollment.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group<br> | Biological: Pediarix TM, Infanrix penta TM<br>* The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.<br>Biological: Hiberix TM<br>* The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PT, anti-FHA and anti-PRN antibody titers. |  | One month after the 3rd dose of the primary vaccination course | 
| Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers |  | One month after the 3rd dose of the primary vaccination course | 
| Anti-HBs antibody titers |  | One month after the 3rd dose of the primary vaccination course | 
| Anti-polio virus types 1, 2 and 3 antibody titers |  | One month after the 3rd dose of the primary vaccination course | 
| Anti-PRP antibody titers |  | One month after the 3rd dose of the primary vaccination course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited adverse events |  | During the 4-day follow-up period after each dose | 
| Occurrence of unsolicited adverse events |  | During the 30-day follow-up period after each dose | 
| Occurrence of Serious Adverse Events |  | Over the course of the study |