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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142490 | Registry Identifier | JapicCTI |
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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.
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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live attenuated measles/rubella combined vaccine | Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 milliliter (mL) of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) | Drug | Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Drug Reactions | 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. | Baseline up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | 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. |
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Inclusion Criteria:
-Vaccinees who meet both of the following conditions [1] and [2]:
Exclusion Criteria:
-
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Measles/rubella
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
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Participants with a historical diagnosis of measles/rubella who received live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) as per routine medical practice were observed in this study.
Participants took part in the study at 152 investigative sites in Japan from 07 February 2006 to 30 April 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Live Attenuated Measles/Rubella Combined Vaccine | Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 milliliter (mL), injection, subcutaneously as a single dose as per routine medical practice were observed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline up to Day 28 |
| COMPLETED |
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| NOT COMPLETED |
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Analysis set included all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Live Attenuated Measles/Rubella Combined Vaccine | Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Predisposition to hypersensitivity | Participants may be represented in more than 1 category. | Number | participants |
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| Complications | 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. Participants may be represented in more than 1 category. | Number | participants |
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| Medical history | 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. Participants may be represented in more than 1 category. | Number | participants |
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| Concomitant medication | Participants may be represented in more than 1 category. | Number | participants |
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| Items that require careful examination before vaccination | Participants were analyzed for any underlying disease such as cardiovascular disease. Allergy related to the components of the freeze-dried live attenuated measles and rubella combined vaccine was reported. Participants may be represented in more than 1 category. | Number | participants |
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| Experience with other vaccine | Number | participants |
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| Type of surveying method after vaccination | Type of surveying method after vaccination included questionnaire, consultation and other survey (for example, call). Participants may be represented in more than 1 category. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Drug Reactions | 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. | Safety analysis set included all participants who received at least one dose of study vaccination. | Posted | Number | participants | Baseline up to Day 28 |
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| Secondary | Number of Participants Reporting One or More Adverse Drug Reactions | 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. | Safety analysis set included all participants who received at least one dose of study vaccination. | Posted | Number | participants | Baseline up to Day 28 |
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Baseline up to Day 28
At each visit the investigator had to document any occurrence of adverse events 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 adverse drug reactions were collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Live Attenuated Measles/Rubella Combined Vaccine | Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed. | 7 | 3,369 | 1,181 | 3,369 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exanthema subitum | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Kawasaki's disease | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA (16.0) | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA (16.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood altered | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Takeda Study Registration Call Center | Takeda | +1-877-825-3327 | medicalinformation@tpna.com |
| ID | Term |
|---|---|
| D008457 | Measles |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
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| Other hypersensitivity |
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| Not determined |
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| Measurements |
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| Hematologic disorders |
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| Psychiatric and nervous system disorders |
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| Cardiovascular disorders |
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| Respiratory disorders |
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| GI disorders |
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| Renal disease |
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| Other complications |
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| Measurements |
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| Psychiatric and nervous system disorders |
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| Cardiovascular disorders |
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| Respiratory disorders |
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| GI disorders |
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| Hepatic and biliary disorders |
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| Renal disease |
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| Other medical history |
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| Neuropsychiatric drugs |
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| GI drugs |
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| Other concomitant medication |
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| History of convulsions |
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| Allergy to components of study vaccine |
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| Not determined or not described |
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| Other survey |
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