NCT02158364|CompletedResults
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Sponsor study identifier
Secondary identifiers
REGISTRY · JapicCTI
OTHER · JapicCTI
observational
3,331
1 country
1
Study Start
March 28, 2007
Actual (reported)Primary Completion
February 20, 2011
Actual (reported)Study Completion
February 20, 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 20, 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2007
Actual (reported)February 20, 2011
Actual (reported)February 20, 2011
Actual (reported)June 4, 2014
Actual (reported)June 6, 2014
Actual (reported)January 29, 2018
Actual (reported)Number of Participants With Serious Adverse Drug Reactions (ADRs)
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.
Up to Day 28
Number of Participants With Adverse Drug Reactions (ADRs)
Up to Day 28
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.
Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Measles/rubella
Osaka, Japan
Study Director
Takeda
3,331 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2014
First Posted
June 6, 2014
Study Start
March 28, 2007
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 20, 2011
Actual (reported)Study Completion
February 20, 2011
Actual (reported)Last Updated
February 23, 2018
Results First Posted
January 29, 2018
Record last verified: 2018-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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