This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Subjects Reporting Solicited General Symptoms
Timeframe: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period
Timeframe: During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period
Timeframe: During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period
Timeframe: During the 31 day follow-up period after each vaccine dose for Year 5 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period
Timeframe: During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period
Timeframe: During the post-marketing study period for Year 1 & Year 2 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period
Timeframe: During the post-marketing study period for Year 3 & Year 4 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period
Timeframe: During the post-marketing study period for Year 5 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period
Timeframe: During the post-marketing study period for Year 1 to Year 6 study period