Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Specified Drug-use Survey of Vaccinees After the Second Vaccination
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,331
- Primary Endpoint
- Number of Participants With Serious Adverse Drug Reactions (ADRs)
Study Overview
Brief Summary
The purpose of this survey is to assess the safety of 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 second vaccination.
Detailed Description
This survey was designed to assess the safety of freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336strain) (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 safety after the second 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."
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Vaccinees who meet both of the following conditions [1] and [2]:
- •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
- •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
Arms & Interventions
Live attenuated measles/rubella combined vaccine
Live attenuated measles/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]), and a 0.5-mL portion is typically administered subcutaneously as a single dose.
Intervention: Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (Drug)
Outcomes
Primary Outcomes
Number of Participants With Serious Adverse Drug Reactions (ADRs)
Time Frame: Up to Day 28
Serious ADRs are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, ADRs were assessed as endpoint.
Secondary Outcomes
- Number of Participants With Adverse Drug Reactions (ADRs)(Up to Day 28)