Tetanus Clinical Trial
Official title:
Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at
2, 3, and 4 months of age in order to meet the regulatory requirements for the license
renewal as for any other product registered in China, and to generate additional clinical
data using the three-dose primary vaccination schedule in some other Chinese provinces.
Primary Objective
- To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age
in the study population.
Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age
and will be monitored for safety through the entire study period.
The duration of each participant in the trial will be approximately 3 to 4 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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