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

Sanofi Pasteur, a Sanofi Company122 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

122

Conditions

Hepatitis B

Interventions

DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccinesBIOLOGICAL

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

DTaP-HB-IPV and Pneumococcal polysaccharide vaccinesBIOLOGICAL

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Bangkok, Thailand

Unnamed facility

Khon Kaen, Thailand

Outcomes

Primary Outcomes

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

Time frame: Day 0

Data from ClinicalTrials.gov

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