Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Special Drug Use Surveillance of Vaccinees After the First Vaccination

Brief 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.

Detailed Summary:

This survey was designed to assess the safety of 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.

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."


Sponsor: Takeda

Current Primary Outcome: Number of Participants With Serious Adverse Drug Reactions [ Time Frame: Baseline up to Day 28 ]

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.


Original Primary Outcome: Frequency of adverse events [ Time Frame: For 28 days ]

For each adverse event, the following will be investigated: [1] Name of adverse event, [2] date of onset, [3] seriousness (if pyrexia is observed, peak body temperature is recorded, and if rash is observed, severity is graded), [4] action taken for the adverse event, [5] outcome, and [6] causal relationship to freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)


Current Secondary Outcome: Number of Participants Reporting One or More Adverse Drug Reactions [ Time Frame: Baseline up to Day 28 ]

Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.


Original Secondary Outcome:

  • Occurrence of adverse drug reactions (adverse events whose causal relationship to freeze-dried live attenuated measles and rubella combined vaccine [Schwarz FF-8 strain/TO-336 strain] cannot be ruled out) [ Time Frame: For 28 days ]
    The overall frequency of adverse drug reactions is calculated.
  • Factors that may influence safety (including the presence/absence of vaccinees requiring careful examination before vaccination) [ Time Frame: For 28 days ]
    The frequency of adverse drug reactions by background factors of vaccinees is calculated.


Information By: Takeda

Dates:
Date Received: May 28, 2014
Date Started: February 2006
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016