Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

Study Overview
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Brief Summary
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This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.

Official Title
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Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)

Conditions
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Diphtheria, Acellular Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study. Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant 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 exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn. 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. 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 the 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)<br>* Three doses administered intramuscularly<br>Biological: OPV<br>* One dose administered orally<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 values |  | One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9) | 

Secondary 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 values |  | Before the first dose ( Month 0 ) | 
| Immunogenicity with respect to the components of the study vaccine in terms of antibody titers |  | Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9). | 
| Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response |  | One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9). | 
| Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values |  | One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9). | 
| Number of subjects with solicited and unsolicited adverse events |  | After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall | 
| Number of subjects with serious adverse events |  | During the study period (Month 0 to Month 9) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine