NCT01444781

Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ Concomitantly Administered With Prevenar™ at 12 to 24 Months of Age in Healthy Latin American Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,106 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

Summary

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: * To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose * To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine. * To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Detailed description

All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine. Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.

Conditions

• Diphtheria
• Tetanus
• Whooping Cough
• Hepatitis B
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide	0.5 mL, Intramuscular each into the right and left deltoid muscle
BIOLOGICAL	DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide	0.5 mL, Intramuscular each into the right and left deltoid muscle
BIOLOGICAL	DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine	0.5 mL (each), Intramuscular each into the right and left deltoid muscle

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-04-01
• Completion: 2013-10-01
• First posted: 2011-10-03
• Last updated: 2014-07-16
• Results posted: 2014-07-16

Locations

2 sites across 2 countries: Colombia, Costa Rica