Freeze-dried live attenuated measles and rubella combined vaccine Takeda Special drug use surveillance of vaccinees after the first vaccinatio

Not Applicable

• Conditions: Measles and rubella

• Registration Number: JPRN-jRCT1080222440
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 3000

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

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events<br>Primary timeframeFor 28 days<br>For each adverse event, 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; 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 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<br>[1] The overall frequency of adverse drug reactions is calculated.<br>[2] The frequency of adverse drug reactions by background factors of vaccinees is calculated.