At a glance
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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
In Brief
A Phase 3 clinical trial evaluating DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, and 1 other intervention for Diphtheria and 4 related conditions. Completed, enrolled 1,106 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular each into the right and left deltoid muscle
0.5 mL, Intramuscular each into the right and left deltoid muscle
0.5 mL (each), Intramuscular each into the right and left deltoid muscle