Measles and rubella
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Vaccinees who meet both of the following conditions [1] and [2]: [1] Vaccinees who have no prior history of either measles or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine "Takeda" as the initial 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events Primary timeframeFor 28 days For each adverse event, the following will be investigated: [1] Name of adverse event, [2] date of onset, [3] seriousness (if pyrexia is observed, peak body temperature is recorded; and if rash is observed, severity is graded), [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
| Measure | Time frame |
|---|---|
| [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) [2] Factors that may influence safety (including the presence/absence of vaccinees requiring careful examination before vaccination) Secondary timeframeFor 28 days [1] The overall frequency of adverse drug reactions is calculated. [2] The frequency of adverse drug reactions by background factors of vaccinees is calculated. | — |
Outcome results
None listed