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
NCT02610348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2018-03-20
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.
Conditions
Interventions
- BIOLOGICAL
-
DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
- BIOLOGICAL
-
DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
Sponsors & Collaborators
-
Sanofi Pasteur, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Medical Director · Sanofi Pasteur SA
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Months
- Max Age
- 18 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2015-12-31
- Completion
- 2016-03-31
Countries
- Thailand
Study Locations
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