Trial Outcomes & Findings for Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Special Drug Use Surveillance of Vaccinees After the First Vaccination (NCT NCT02151773)
NCT ID: NCT02151773
Last Updated: 2017-01-31
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
3493 participants
Primary outcome timeframe
Baseline up to Day 28
Results posted on
2017-01-31
Participant Flow
Participants took part in the study at 152 investigative sites in Japan from 07 February 2006 to 30 April 2009.
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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3493
|
|
Overall Study
COMPLETED
|
3429
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Protocol Deviation
|
64
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Baseline Characteristics
Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Special Drug Use Surveillance of Vaccinees After the First Vaccination
Baseline characteristics by cohort
| Measure |
Live Attenuated Measles/Rubella Combined Vaccine
n=3429 Participants
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.
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|---|---|
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Age, Customized
>=12 to less than (<)18 months
|
2921 participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 18 months
|
508 participants
n=5 Participants
|
|
Gender
Female
|
1670 Participants
n=5 Participants
|
|
Gender
Male
|
1759 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
3429 participants
n=5 Participants
|
|
Predisposition to hypersensitivity
Drug hypersensitivity
|
10 participants
n=5 Participants
|
|
Predisposition to hypersensitivity
Food hypersensitivity
|
187 participants
n=5 Participants
|
|
Predisposition to hypersensitivity
Other hypersensitivity
|
23 participants
n=5 Participants
|
|
Predisposition to hypersensitivity
Not determined
|
41 participants
n=5 Participants
|
|
Complications
Congenital anomalies
|
20 participants
n=5 Participants
|
|
Complications
Endocrine disorders
|
1 participants
n=5 Participants
|
|
Complications
Hematologic disorders
|
8 participants
n=5 Participants
|
|
Complications
Psychiatric and nervous system disorders
|
18 participants
n=5 Participants
|
|
Complications
Cardiovascular disorders
|
14 participants
n=5 Participants
|
|
Complications
Respiratory disorders
|
139 participants
n=5 Participants
|
|
Complications
GI disorders
|
11 participants
n=5 Participants
|
|
Complications
Renal disease
|
4 participants
n=5 Participants
|
|
Complications
Other complications
|
120 participants
n=5 Participants
|
|
Medical history
Congenital anomalies
|
19 participants
n=5 Participants
|
|
Medical history
Hematologic disorders
|
10 participants
n=5 Participants
|
|
Medical history
Psychiatric and nervous system disorders
|
54 participants
n=5 Participants
|
|
Medical history
Cardiovascular disorders
|
25 participants
n=5 Participants
|
|
Medical history
Respiratory disorders
|
149 participants
n=5 Participants
|
|
Medical history
GI disorders
|
49 participants
n=5 Participants
|
|
Medical history
Hepatic and biliary disorders
|
3 participants
n=5 Participants
|
|
Medical history
Renal disease
|
2 participants
n=5 Participants
|
|
Medical history
Other medical history
|
177 participants
n=5 Participants
|
|
Concomitant medication
Not determined or not described
|
10 participants
n=5 Participants
|
|
Concomitant medication
Antibiotic drugs
|
17 participants
n=5 Participants
|
|
Concomitant medication
Neuropsychiatric drugs
|
5 participants
n=5 Participants
|
|
Concomitant medication
GI drugs
|
21 participants
n=5 Participants
|
|
Concomitant medication
Other concomitant medication
|
117 participants
n=5 Participants
|
|
Items that require careful examination before vaccination
Underlying disease
|
48 participants
n=5 Participants
|
|
Items that require careful examination before vaccination
Pyrexia and generalized rash
|
4 participants
n=5 Participants
|
|
Items that require careful examination before vaccination
History of convulsions
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33 participants
n=5 Participants
|
|
Items that require careful examination before vaccination
Allergy to components of study vaccine
|
49 participants
n=5 Participants
|
|
Experience with other vaccine
Prior exposure to vaccine
|
3315 participants
n=5 Participants
|
|
Experience with other vaccine
No prior exposure to vaccine
|
92 participants
n=5 Participants
|
|
Experience with other vaccine
Not determined or not described
|
22 participants
n=5 Participants
|
|
Type of surveying method after vaccination
Questionnaire
|
3149 participants
n=5 Participants
|
|
Type of surveying method after vaccination
Consultation
|
1230 participants
n=5 Participants
|
|
Type of surveying method after vaccination
Other survey
|
154 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: Safety analysis set included all participants who received at least one dose of study vaccination.
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.
Outcome measures
| Measure |
Live Attenuated Measles/Rubella Combined Vaccine
n=3369 Participants
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.
|
|---|---|
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Number of Participants With Serious Adverse Drug Reactions
|
7 participants
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SECONDARY outcome
Timeframe: Baseline up to Day 28Population: Safety analysis set included all participants who received at least one dose of study vaccination.
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.
Outcome measures
| Measure |
Live Attenuated Measles/Rubella Combined Vaccine
n=3369 Participants
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.
|
|---|---|
|
Number of Participants Reporting One or More Adverse Drug Reactions
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1183 participants
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Adverse Events
Live Attenuated Measles/Rubella Combined Vaccine
Serious events: 7 serious events
Other events: 1181 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Live Attenuated Measles/Rubella Combined Vaccine
n=3369 participants at risk
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.
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|---|---|
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Infections and infestations
Exanthema subitum
|
0.03%
1/3369 • 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.
|
|
Nervous system disorders
Convulsion
|
0.09%
3/3369 • 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.
|
|
Vascular disorders
Kawasaki's disease
|
0.03%
1/3369 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3369 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.06%
2/3369 • 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.
|
|
General disorders
Pyrexia
|
0.15%
5/3369 • 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.
|
|
Investigations
White blood cell count increased
|
0.03%
1/3369 • 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.
|
|
Investigations
C-reactive protein increased
|
0.03%
1/3369 • 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.
|
Other adverse events
| Measure |
Live Attenuated Measles/Rubella Combined Vaccine
n=3369 participants at risk
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.
|
|---|---|
|
Psychiatric disorders
Mood altered
|
3.9%
132/3369 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
307/3369 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.9%
436/3369 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
178/3369 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
316/3369 • 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.
|
|
General disorders
Injection site erythema
|
4.2%
141/3369 • 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.
|
|
General disorders
Pyrexia
|
18.8%
633/3369 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER