Tetanus Clinical Trial
Official title:
Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
Primary Objective:
- To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for
all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one
month after a three-dose primary series.
Secondary Objectives:
- To describe in each group the immunogenicity parameters one month after the three-dose
primary series.
- To describe safety profile after each vaccination in both groups.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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