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

Status: Completed

Conditions: Hepatitis B

Treatments: Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines; Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Study type: Interventional

Funder types: Industry

Identifiers

NCT02610348

A3L47

U1111-1161-2649 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Group A

Experimental group

Description:

Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12

Treatment:

Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

Group B

Experimental group

Description:

Toddlers vaccinated with Infanrix hexa® in study A3L12

Treatment:

Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines