NCT00654901

Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 881 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 15 Months – 18 Months
• Healthy volunteers: Accepted

Summary

This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\~T or Infanrix hexa™. * To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP\~T in a subset of subjects. Safety \- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP\~T.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Poliomyelitis
• Haemophilus Influenzae Type B Infection

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)	0.5 mL, Intramuscular
BIOLOGICAL	Infanrix Hexa™	0.5 mL, Intramuscular

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-05-01
• Completion: 2009-07-01
• First posted: 2008-04-09
• Last updated: 2016-05-13
• Results posted: 2013-06-26

Locations

4 sites across 1 country: Mexico