Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age

Study Overview
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Brief Summary
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Primary Objective: To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.

Detailed Description
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Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.

Official Title
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Persistence of Anti-Hep B Antibodies at 12 to 18 Months of Age in Children Having Received Hep B Vaccine at Birth and a DTaP-IPV-HB-Hib Hexavalent Vaccine (Hexaxim® or Infanrix Hexa®) Concomitantly With Prevnar® at 2, 4 and 6 Months of Age

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: DTaP-IPV-HB-PRP T and Pneumococcal polysaccharide vaccines
* Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects having received 4 Hep B doses in A3L12 (i.e. one dose at birth + three doses during study at 2, 4 & 6 months of age) Subjects having participated in PNA19 Subject's parents having given authorization to use serum collected in PNA19 for future research The initials, birth date, and gender of the subject are consistent between A3L12 and PNA19 databases Subjects for whom retention sera are of enough volume to allow a valid determination of the HBsAg antibody level. Exclusion Criteria: Not applicable.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12 | Biological: DTaP-IPV-HB-PRP T and Pneumococcal polysaccharide vaccines<br>* Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study<br>|
| Experimental: Group B<br>Toddlers vaccinated with Infanrix hexa® in study A3L12 | Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines<br>* Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study | Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Hexaxim®, Hexyon®, Hexacima®, Prevnar®, DTaP-IPV-HB-Hib hexavalent vaccine