NCT02610348

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2015-11-20
• Last updated: 2018-03-20

Locations

2 sites across 1 country: Thailand