ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 141 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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Measles/Rubella
Intervention Drug: Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)
Enrollment 3331
Recruitment Details Participants took part in the study at 147 investigative sites in Japan, from 28-Mar-2007 to 20-Feb-2011.
Pre-assignment Details Participants with a history of initial vaccination with live attenuated measles/rubella combined vaccine who received second vaccination with live attenuated measles/rubella combined vaccine as per routine medical practice were observed in this study.
Arm/Group Title Live Attenuated Measles/Rubella Combined Vaccine
Hide Arm/Group Description 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. Participants received interventions as part of routine medical care.
Period Title: Overall Study
Started 3331
Completed 3271
Not Completed 60
Reason Not Completed
Case report forms uncollected             10
Protocol Deviation             50
Arm/Group Title Live Attenuated Measles/Rubella Combined Vaccine
Hide Arm/Group Description 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. Participants received interventions as part of routine medical care.
Overall Number of Baseline Participants 3271
Hide Baseline Analysis Population Description
Safety Analysis Set: All the enrolled participants who were completed the study without any protocol deviations and collected case report forms.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3271 participants
5.5  (1.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Female
1601
  48.9%
Male
1670
  51.1%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 3271 participants
3271
[1]
Measure Description: All participants were enrolled in Japan.
Predisposition to Hypersensitivity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Had Predisposition to Hypersensitivity
403
  12.3%
Had no Predisposition to Hypersensitivity
2868
  87.7%
Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Had Complications
257
   7.9%
Had No Complications
3014
  92.1%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Medical History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Had Medical History
492
  15.0%
Had No Medical History
2779
  85.0%
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.
Concurrent Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Had Concurrent Medication(s)
169
   5.2%
Had No Concurrent Medication
3099
  94.7%
Unknown/not reported
3
   0.1%
Cautions to Vaccination  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Had Cautions
169
   5.2%
Had no Cautions
3102
  94.8%
History of Vaccination with Measles Vaccine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Received the Vaccine
2902
  88.7%
Unknown/not reported
369
  11.3%
History of Vaccination with Rubella Vaccine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Received the Vaccine
2871
  87.8%
Unknown/not reported
400
  12.2%
History of Vaccination with Measles/Rubella Combined Vaccine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3271 participants
Received the Vaccine
351
  10.7%
Unknown/not reported
2920
  89.3%
Type of Surveying Method after Vaccination   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3271 participants
Questionnaire, Available 3023
Questionnaire, not Available 248
Physician’s Visit, Yes 653
Physician’s Visit, No 2618
Other, Yes 147
Other, No 3124
[1]
Measure Description: Type of surveying method after vaccination included questionnaire, consultation and other survey (for example, call). Participants may be represented in more than 1 category.
1.Primary Outcome
Title Number of Participants With Serious Adverse Drug Reactions (ADRs)
Hide Description 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.
Time Frame Up to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Vaccinated Safety Analysis Set included all participants who received measles/rubella combined vaccine "Takeda" as the second vaccination. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Live Attenuated Measles/Rubella Combined Vaccine
Hide Arm/Group Description:
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. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 3225
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.1%
2.Secondary Outcome
Title Number of Participants With Adverse Drug Reactions (ADRs)
Hide Description 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.
Time Frame Up to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Vaccinated Safety Analysis Set included all participants who received measles/rubella combined vaccine "Takeda" as the second vaccination. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Live Attenuated Measles/Rubella Combined Vaccine
Hide Arm/Group Description:
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. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 3225
Measure Type: Count of Participants
Unit of Measure: Participants
590
  18.3%
Time Frame Up to Day 28
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
 
Arm/Group Title Live Attenuated Measles/Rubella Combined Vaccine
Hide Arm/Group Description 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. Participants received interventions as part of routine medical care.
All-Cause Mortality
Live Attenuated Measles/Rubella Combined Vaccine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Live Attenuated Measles/Rubella Combined Vaccine
Affected / at Risk (%)
Total   2/3225 (0.06%) 
Nervous system disorders   
Convulsion  1  1/3225 (0.03%) 
Epilepsy  1  1/3225 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Live Attenuated Measles/Rubella Combined Vaccine
Affected / at Risk (%)
Total   376/3225 (11.66%) 
General disorders   
Injection site erythema  1  214/3225 (6.64%) 
Pyrexia  1  162/3225 (5.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
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 Submitted: June 4, 2014
First Posted: June 6, 2014
Results First Submitted: July 26, 2017
Results First Posted: January 29, 2018
Last Update Posted: February 23, 2018