Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™

Study Overview
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Brief Summary
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The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.

Official Title
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Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™

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

Intervention / Treatment
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* Procedure: Blood Sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034. Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol. A male or female subject aged 5 years at the time of study entry. Written informed consent obtained from the parent(s)/LAR(s) of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: Child in care. 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. Use of any investigational or non-registered product within 30 days prior to blood sampling. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group. Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Family history of congenital or hereditary immunodeficiency.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infanrix hexa Group<br>Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034. | Procedure: Blood Sampling<br>* A blood sample will be taken at 5 years of age, after vaccination in the primary study.<br>|
| Experimental: Infanrix-IPV/Hib Group<br>Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034. | Procedure: Blood Sampling<br>* A blood sample will be taken at 5 years of age, after vaccination in the primary study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). | A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL) | At Day 0 | 
| Concentrations of Antibodies Against Anti-D and Anti-T | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). | At Day 0 | 
| Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL). | Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination. | At Day 0 | 
| Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL). | At Day 0 | 
| Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs). | Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL). | At Day 0 | 
| Concentrations of Antibodies Against Anti-HBs. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). | At Day 0 | 
| Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP). | A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL) | At Day 0 | 
| Concentrations of Antibodies Against Anti-PRP. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL). | At Day 0 | 
| Number of Subjects With Serious Adverse Events (SAEs). | Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (up to Day 46) | 
| Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL | Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination. | At Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infanrix-IPV/Hib, Long-term follow up, Persistence, Infanrix hexa