Freeze-dried live attenuated measles and rubella combined vaccine Takeda Specified drug-use survey of vaccinees after the second vaccinatio
Not Applicable
- Conditions
- Measles and rubella
- Registration Number
- JPRN-jRCT1080222457
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
Vaccinees who meet both of the following conditions [1] and [2]:
[1] Vaccinees who have a prior history of receiving measles and/or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine Takeda as the second vaccination
[2] Vaccinees whose guardians are able to participate in a questionnaire survey on the health status of vaccinees after vaccination with freeze-dried live attenuated measles and rubella combined vaccine Takeda
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events<br>Primary timeframeFor 28 days<br>For each adverse event occurring immediately after or after vaccination with freeze-dried live attenuated measles and rubella combined vaccine Takeda, the following will be investigated:<br>[1] Name of adverse event, [2] date of onset, [3] seriousness (if pyrexia is observed, peak body temperature is recorded; if injection site reactions [induration] or rash is observed, its severity is graded; and if other type of injection site reactions [redness or swelling] are observed, the longest diameter is recorded), [4] action taken for the adverse event, [5] outcome, and [6] causal relationship to freeze-dried live attenuated measles and rubella combined vaccine Takeda
- Secondary Outcome Measures
Name Time Method [1] Occurrence of adverse drug reactions (adverse events whose causal relationship to freeze-dried live attenuated measles and rubella combined vaccine Takeda cannot be ruled out)<br>[2] Factors that may influence safety (including the presence/absence of vaccinees requiring careful examination before vaccination )<br>Secondary timeframeFor 28 days