Measles/Rubella
Conditions
Keywords
Pharmacological therapy
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.
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.
Interventions
Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Drug Reactions (ADRs) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | 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. |
Countries
Japan
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,271 |
| Total | 3,271 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case report forms uncollected | 10 |
| Overall Study | Protocol Deviation | 50 |
Baseline characteristics
| Characteristic | Live Attenuated Measles/Rubella Combined Vaccine |
|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 1.21 |
| Cautions to Vaccination Had Cautions | 169 Participants |
| Cautions to Vaccination Had no Cautions | 3102 Participants |
| Complications Had Complications | 257 Participants |
| Complications Had No Complications | 3014 Participants |
| Concurrent Medication Had Concurrent Medication(s) | 169 Participants |
| Concurrent Medication Had No Concurrent Medication | 3099 Participants |
| Concurrent Medication Unknown/not reported | 3 Participants |
| History of Vaccination with Measles/Rubella Combined Vaccine Received the Vaccine | 351 Participants |
| History of Vaccination with Measles/Rubella Combined Vaccine Unknown/not reported | 2920 Participants |
| History of Vaccination with Measles Vaccine Received the Vaccine | 2902 Participants |
| History of Vaccination with Measles Vaccine Unknown/not reported | 369 Participants |
| History of Vaccination with Rubella Vaccine Received the Vaccine | 2871 Participants |
| History of Vaccination with Rubella Vaccine Unknown/not reported | 400 Participants |
| Medical History Had Medical History | 492 Participants |
| Medical History Had No Medical History | 2779 Participants |
| Predisposition to Hypersensitivity Had no Predisposition to Hypersensitivity | 2868 Participants |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 403 Participants |
| Region of Enrollment Japan | 3271 Participants |
| Sex: Female, Male Female | 1601 Participants |
| Sex: Female, Male Male | 1670 Participants |
| Type of Surveying Method after Vaccination Other, No | 3124 Participants |
| Type of Surveying Method after Vaccination Other, Yes | 147 Participants |
| Type of Surveying Method after Vaccination Physician's Visit, No | 2618 Participants |
| Type of Surveying Method after Vaccination Physician's Visit, Yes | 653 Participants |
| Type of Surveying Method after Vaccination Questionnaire, Available | 3023 Participants |
| Type of Surveying Method after Vaccination Questionnaire, not Available | 248 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 376 / 3,225 |
| serious Total, serious adverse events | 2 / 3,225 |
Outcome results
Primary
Number of Participants With Serious Adverse Drug Reactions (ADRs)
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Live Attenuated Measles/Rubella Combined Vaccine | Number of Participants With Serious Adverse Drug Reactions (ADRs) | 2 Participants |
Secondary
Number of Participants With Adverse Drug Reactions (ADRs)
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Live Attenuated Measles/Rubella Combined Vaccine | Number of Participants With Adverse Drug Reactions (ADRs) | 590 Participants |