Overview

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

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
Vaccines
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 (Schwarz
FF-8 strain/TO-336 strain) 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 (Schwarz FF-8 strain/TO-336 strain).

Exclusion Criteria:

-