Clinical Trial: Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Special Drug Use Surveillance of Vaccinees After the First Vaccination
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Special Drug Use Surveillance of Vaccinees After the First Vaccination
Brief Summary: The purpose of this survey is to assess the safety freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.
Detailed Summary:
This survey was designed to assess the safety of live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.
Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), wherein a 0.5-mL portion is typically administered subcutaneously as a single dose.
In addition, freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) should be used in accordance with the "Regulations for Vaccination" and the "Guidelines for Routine Vaccination."
Sponsor: Takeda
Current Primary Outcome: Number of Participants With Serious Adverse Drug Reactions [ Time Frame: Baseline up to Day 28 ]
Original Primary Outcome: Frequency of adverse events [ Time Frame: For 28 days ]
Current Secondary Outcome: Number of Participants Reporting One or More Adverse Drug Reactions [ Time Frame: Baseline up to Day 28 ]
Original Secondary Outcome:
- Occurrence of adverse drug reactions (adverse events whose causal relationship to freeze-dried live attenuated measles and rubella combined vaccine [Schwarz FF-8 strain/TO-336 strain] cannot be ruled out) [ Time Frame: For 28 days ]The overall frequency of adverse drug reactions is calculated.
- Factors that may influence safety (including the presence/absence of vaccinees requiring careful examination before vaccination) [ Time Frame: For 28 days ]The frequency of adverse drug reactions by background factors of vaccinees is calculated.
Information By: Takeda
Dates:
Date Received: May 28, 2014
Date Started: February 2006
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016