Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age

Study Overview
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Brief Summary
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The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.

Official Title
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A Phase II, Observer-blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Combined DssiTgdPa-HBV-IPV/Hib Vaccine Containing Diphtheria Toxoid From the Statens Serum Institute (SSI) of Denmark and Tetanus Toxoid From GSK Biologicals' Kft [GD], Compared to the Currently Licensed GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa TM) When Administered to Healthy Infants at 2, 3 and 4 Months of Age.

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

Intervention / Treatment
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* Biological: Infanrix hexa Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination. Written informed consent obtained from the parents/guardians of the subject. Born after a normal gestation period of 36 to 42 weeks. Exclusion Criteria: Use of any investigational or non-registered product (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. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenza type b (Hib) vaccination or disease. Hepatitis B virus (HBV) vaccination at birth. History of seizures or progressive neurological disease.

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 12 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Infanrix hexa Vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody concentration/response to all vaccine antigens after vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited (D0-3); unsolicited events (D0-30); serious adverse events (SAEs) (full study) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Finland, Haemophilus influenzae type b, Double-blind, randomized, phase 2, GSK Biologicals, DTPa-HBV-IPV/Hib