Measles/Rubella
Conditions
Keywords
Pharmacological therapy
Brief summary
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.
Detailed description
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.
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 no prior history of either measles or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) as the initial 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 (Schwarz FF-8 strain/TO-336 strain).
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Drug Reactions | Baseline up to Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to Day 28 | 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. |
Participant flow
Recruitment details
Participants took part in the study at 152 investigative sites in Japan from 07 February 2006 to 30 April 2009.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 3,429 |
| Total | 3,429 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Deviation | 64 |
Baseline characteristics
| Characteristic | Live Attenuated Measles/Rubella Combined Vaccine |
|---|---|
| Age, Customized >=12 to less than (<)18 months | 2921 participants |
| Age, Customized Greater than or equal to (>=) 18 months | 508 participants |
| Complications Cardiovascular disorders | 14 participants |
| Complications Congenital anomalies | 20 participants |
| Complications Endocrine disorders | 1 participants |
| Complications GI disorders | 11 participants |
| Complications Hematologic disorders | 8 participants |
| Complications Other complications | 120 participants |
| Complications Psychiatric and nervous system disorders | 18 participants |
| Complications Renal disease | 4 participants |
| Complications Respiratory disorders | 139 participants |
| Concomitant medication Antibiotic drugs | 17 participants |
| Concomitant medication GI drugs | 21 participants |
| Concomitant medication Neuropsychiatric drugs | 5 participants |
| Concomitant medication Not determined or not described | 10 participants |
| Concomitant medication Other concomitant medication | 117 participants |
| Experience with other vaccine No prior exposure to vaccine | 92 participants |
| Experience with other vaccine Not determined or not described | 22 participants |
| Experience with other vaccine Prior exposure to vaccine | 3315 participants |
| Gender Female | 1670 Participants |
| Gender Male | 1759 Participants |
| Items that require careful examination before vaccination Allergy to components of study vaccine | 49 participants |
| Items that require careful examination before vaccination History of convulsions | 33 participants |
| Items that require careful examination before vaccination Pyrexia and generalized rash | 4 participants |
| Items that require careful examination before vaccination Underlying disease | 48 participants |
| Medical history Cardiovascular disorders | 25 participants |
| Medical history Congenital anomalies | 19 participants |
| Medical history GI disorders | 49 participants |
| Medical history Hematologic disorders | 10 participants |
| Medical history Hepatic and biliary disorders | 3 participants |
| Medical history Other medical history | 177 participants |
| Medical history Psychiatric and nervous system disorders | 54 participants |
| Medical history Renal disease | 2 participants |
| Medical history Respiratory disorders | 149 participants |
| Predisposition to hypersensitivity Drug hypersensitivity | 10 participants |
| Predisposition to hypersensitivity Food hypersensitivity | 187 participants |
| Predisposition to hypersensitivity Not determined | 41 participants |
| Predisposition to hypersensitivity Other hypersensitivity | 23 participants |
| Region of Enrollment Japan | 3429 participants |
| Type of surveying method after vaccination Consultation | 1230 participants |
| Type of surveying method after vaccination Other survey | 154 participants |
| Type of surveying method after vaccination Questionnaire | 3149 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,181 / 3,369 |
| serious Total, serious adverse events | 7 / 3,369 |
Outcome results
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.
Time frame: Baseline up to Day 28
Population: Safety analysis set included all participants who received at least one dose of study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Attenuated Measles/Rubella Combined Vaccine | Number of Participants With Serious Adverse Drug Reactions | 7 participants |
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.
Time frame: Baseline up to Day 28
Population: Safety analysis set included all participants who received at least one dose of study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Attenuated Measles/Rubella Combined Vaccine | Number of Participants Reporting One or More Adverse Drug Reactions | 1183 participants |