NCT02151773|CompletedResults
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Sponsor study identifier
Secondary identifiers
REGISTRY · JapicCTI
observational
3,493
0 countries
N/A
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Actual (reported)Study Completion
April 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2009
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.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 2009
Actual (reported)April 2009
Actual (reported)May 28, 2014
Actual (reported)May 30, 2014
Actual (reported)January 31, 2017
Actual (reported)Number of Participants With Serious Adverse Drug Reactions
Serious adverse drug reactions 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, adverse drug reactions were assessed as endpoint.
Baseline up to Day 28
Number of Participants Reporting One or More Adverse Drug Reactions
Baseline up to Day 28
Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 milliliter (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
Postmarketing Group Manager
Takeda
3,493 participants (actual enrollment reported by the registry).
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2009
Actual (reported)Study Completion
April 2009
Actual (reported)Last Updated
January 31, 2017
Results First Posted
January 31, 2017
Record last verified: 2016-12
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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