Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

Study Overview
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Brief Summary
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This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.

Official Title
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Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately

Conditions
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Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis, Pertussis, Tetanus

Intervention / Treatment
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* Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)
* Biological: DTPa-HBV-IPV (Infanrix penta™)
* Biological: Hib (Hiberix™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A male or female 3 months 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: The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination. Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease. History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of allergic disease or reactions 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. History of seizures or of any neurological disease at study entry. Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period. Acute disease at time of enrolment

Ages Eligible for Study
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Minimum Age: 12 Weeks
Maximum Age: 16 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine. | Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)<br>* Three doses administered intramuscularly<br>|
| Active Comparator: Group B<br>Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine. | Biological: DTPa-HBV-IPV (Infanrix penta™)<br>* Three doses administered intramuscularly<br>Biological: Hib (Hiberix™)<br>* Three doses administered intramuscularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value |  | One month after the 2nd dose of the primary vaccination course ( Month 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects |  | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) | 
| Immunogenicity with respect to the 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 ( Month 8 and 9) | 
| Immunogenicity with respect to the components of the study vaccines in terms of antibody titres |  | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) | 
| Immunogenicity with respect to the components of the study vaccines in terms of vaccine response |  | One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3) | 
| Occurrence of solicited local symptoms |  | Within 4 days after each vaccination and overall | 
| Occurrence of solicited general symptoms |  | Within 4 days after each vaccination and overall | 
| Occurrence of unsolicited symptoms |  | Within 30 days after each vaccination and overall | 
| Occurrence of serious adverse events |  | Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combination vaccine, DTPa-HBV-IPV, Hib