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Trial record 18 of 140 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

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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 147 investigative sites in Japan, from 28-Mar-2007 to 20-Feb-2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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. Participants received interventions as part of routine medical care.

Participant Flow:   Overall Study
    Live Attenuated Measles/Rubella Combined Vaccine
STARTED   3331 
COMPLETED   3271 
NOT COMPLETED   60 
Case report forms uncollected                10 
Protocol Deviation                50 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set: All the enrolled participants who were completed the study without any protocol deviations and collected case report forms.

Reporting Groups
  Description
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. Participants received interventions as part of routine medical care.

Baseline Measures
   Live Attenuated Measles/Rubella Combined Vaccine 
Overall Participants Analyzed 
[Units: Participants]
 3271 
Age 
[Units: Years]
Mean (Standard Deviation)
 5.5  (1.21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1601  48.9% 
Male      1670  51.1% 
Region of Enrollment [1] 
[Units: Participants]
 
Japan   3271 
[1] All participants were enrolled in Japan.
Predisposition to Hypersensitivity 
[Units: Participants]
Count of Participants
 
Had Predisposition to Hypersensitivity   403 
Had no Predisposition to Hypersensitivity   2868 
Complications [1] 
[Units: Participants]
Count of Participants
 
Had Complications   257 
Had No Complications   3014 
[1] 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] 
[Units: Participants]
Count of Participants
 
Had Medical History   492 
Had No Medical History   2779 
[1] 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 
[Units: Participants]
Count of Participants
 
Had Concurrent Medication(s)   169 
Had No Concurrent Medication   3099 
Unknown/not reported   3 
Cautions to Vaccination 
[Units: Participants]
Count of Participants
 
Had Cautions   169 
Had no Cautions   3102 
History of Vaccination with Measles Vaccine 
[Units: Participants]
Count of Participants
 
Received the Vaccine   2902 
Unknown/not reported   369 
History of Vaccination with Rubella Vaccine 
[Units: Participants]
Count of Participants
 
Received the Vaccine   2871 
Unknown/not reported   400 
History of Vaccination with Measles/Rubella Combined Vaccine 
[Units: Participants]
Count of Participants
 
Received the Vaccine   351 
Unknown/not reported   2920 
Type of Surveying Method after Vaccination [1] 
[Units: 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] Type of surveying method after vaccination included questionnaire, consultation and other survey (for example, call). Participants may be represented in more than 1 category.


  Outcome Measures

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

2.  Secondary:   Number of Participants With Adverse Drug Reactions (ADRs)   [ Time Frame: Up to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



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