N/A
N=3,493
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
Measles/Rubella
Bottom Line
View on ClinicalTrials.gov: NCT02151773 ↗Enrolled (actual)
3,493
Serious AEs
0.2%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants With Serious Adverse Drug Reactions — 7 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Drug Reactions |
7 | — |
| SECONDARY Number of Participants Reporting One or More Adverse Drug Reactions |
1183 | — |
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.
Eligibility Criteria
Inclusion Criteria
-Vaccinees who meet both of the following conditions [1] and [2]:
- 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.
- 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
-
Data sourced from ClinicalTrials.gov (NCT02151773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.