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Trial record 18 of 139 for:    "Measles"

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

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ClinicalTrials.gov Identifier: NCT02158364
Recruitment Status : Completed
First Posted : June 6, 2014
Results First Posted : January 29, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment
Measles/Rubella Drug: Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)

Detailed Description:

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."


Study Type : Observational
Actual Enrollment : 3331 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Specified Drug-use Survey of Vaccinees After the Second Vaccination
Actual Study Start Date : March 28, 2007
Actual Primary Completion Date : February 20, 2011
Actual Study Completion Date : February 20, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Rubella
U.S. FDA Resources

Group/Cohort Intervention/treatment
Live attenuated measles/rubella combined vaccine
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.
Drug: 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 (Schwarz FF-8 strain/TO-336 strain)
Other Name: Freeze-dried live attenuated measles and rubella combined vaccine "Takeda"



Primary Outcome Measures :
  1. Number of Participants With Serious Adverse Drug Reactions (ADRs) [ Time Frame: Up to Day 28 ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Drug Reactions (ADRs) [ Time Frame: Up to Day 28 ]
    ADRs are defined as adverse events (AEs) 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Measles/rubella
Criteria

Inclusion Criteria:

Vaccinees who meet both of the following conditions [1] and [2]:

  1. Vaccinees who have a prior history of receiving measles and/or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine "Takeda" as the second vaccination
  2. 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 "Takeda"

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158364


Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Study Director Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02158364     History of Changes
Other Study ID Numbers: 247-012
JapicCTI- 142507 ( Registry Identifier: JapicCTI )
JapicCTI-R171016 ( Other Identifier: JapicCTI )
First Posted: June 6, 2014    Key Record Dates
Results First Posted: January 29, 2018
Last Update Posted: February 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Measles
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs