Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

Summary

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.

Timeline

Start

2011-12

Primary completion

2012-07

Completion

2012-12

Drugs

Indications