Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course

Study Overview
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Brief Summary
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The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.

Official Title
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Study to Assess and Compare the Immunogenicity and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD's DTPa-HBV-IPV-Hib Vaccine (HEXAVAC™) Given at 3, 5 and 11-12 Months of Age

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

Intervention / Treatment
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* Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)
* Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject prior to the study entry. Free of obvious health problems as established by medical history and clinical examination before entering into the study. 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 within 30 days preceding the administration of the study vaccine, or planned use during the study period. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease. Planned administration of a vaccine not foreseen by the study protocol since birth and during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose of the three-dose primary vaccination course, with the exception of licensed Neisseria meningitides conjugate vaccines or Bacillus Calmette-Guérin (BCG) vaccine that can be given in between study visits or after the third visit, provided they are given preferably with a 4 weeks interval but not less than 3 weeks apart from the study vaccine doses. Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs since birth. Planned administration of immunoglobulins and/or any blood products since birth or planned administration during the period up to 30 days after the third dose of the primary vaccination course. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of seizures, progressive neurological disease or intra-cerebral haemorrhage. Major congenital defects or serious chronic illness. Acute febrile illness at the time of planned vaccination History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTPa 1 Group<br> | Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)<br>* Three doses administered intramuscularly<br>|
| Active Comparator: DTPa 2 Group<br> | Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)<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 antibody concentrations |  | Prior to the third primary vaccination dose ( Months 8-9) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations |  | One month after the second and third primary vaccination dose (Month 3 and Months 9-10) | 
| Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected subjects defined by antibody concentration |  | Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10) | 
| Immunogenicity with respect to the components of the study vaccine in terms of number of seropositive subjects |  | Prior to and one month after the third primary vaccination dose ( Months 8-9 and Months 9-10) | 
| Occurrence of solicited symptoms |  | Within 4 days (Day 0 -Day 3) after each vaccine dose | 
| Occurrence of a grade 3 solicited symptoms |  | Within 4 days (Day 0 -Day 3) after each vaccine dose | 
| Occurrence of unsolicited adverse events |  | Within 31 days after any vaccination | 
| Occurrence of Serious Adverse Events |  | Throughout the entire study up to (Month 0 to Month 9-10) and including 30 days after last vaccination (Month 9-10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HEXAVACTM, InfanrixTM HEXA, DTPa-HBV-IPV-Hib, DTPa-HBV-IPV/Hib