Clinical Trial: Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Specified Drug-use Survey of Vaccinees After the Second Vaccination

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

Official Title: Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Specified Drug-use Survey of Vaccinees After the Second Vaccination

Brief Summary: 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.

Detailed Summary:

This survey was designed to assess the safety of freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336strain) (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 safety after the second 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: 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; if injection site reactions [induration] or rash is observed, its severity is graded; and if other type of injection site reactions [redness or swelling] are observed, the longest diameter is recorded), [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)



Original Primary Outcome: Same as current

Current 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.


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: June 4, 2014
Date Started: March 2007
Date Completion:
Last Updated: June 4, 2014
Last Verified: June 2014