Safety of 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.
- To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.
|Diphtheria Tetanus Pertussis Polio||Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine [ Time Frame: Day 0 for up to 3 months post vaccination ]Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability
|Study Start Date:||December 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: PENTAXIM® vaccine group||
Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®
0.5 mL, Intramuscular
Other Name: PENTAXIM®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491087
|Guangzhou, Guangdong, China, 510300|
|Shanghai, China, 200336|
|Tianjin, China, 300011|
|Study Director:||Medical Director||Sanofi Pasteur SA|