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

Not Applicable

Completed

• Conditions: Hepatitis B
• Interventions: Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines; Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

• Registration Number: NCT02610348
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	DTaP-HB-IPV and Pneumococcal polysaccharide vaccines	Toddlers vaccinated with Infanrix hexa® in study A3L12
Group A	DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines	Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12

Primary Outcome Measures

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