Trial Outcomes & Findings for 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 (NCT NCT02158364)

Last Updated: 2018-02-23

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

3331 participants

Primary outcome timeframe

Up to Day 28

Results posted on

2018-02-23

Participant Flow

Participants took part in the study at 147 investigative sites in Japan, from 28-Mar-2007 to 20-Feb-2011.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3331
Overall Study COMPLETED	3271
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Case report forms uncollected	10
Overall Study Protocol Deviation	50

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Live Attenuated Measles/Rubella Combined Vaccine n=3271 Participants 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.
Age, Continuous	5.5 years STANDARD_DEVIATION 1.21 • n=5 Participants
Sex: Female, Male Female	1601 Participants n=5 Participants
Sex: Female, Male Male	1670 Participants n=5 Participants
Region of Enrollment Japan	3271 Participants n=5 Participants
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	403 Participants n=5 Participants
Predisposition to Hypersensitivity Had no Predisposition to Hypersensitivity	2868 Participants n=5 Participants
Complications Had Complications	257 Participants n=5 Participants
Complications Had No Complications	3014 Participants n=5 Participants
Medical History Had Medical History	492 Participants n=5 Participants
Medical History Had No Medical History	2779 Participants n=5 Participants
Concurrent Medication Had Concurrent Medication(s)	169 Participants n=5 Participants
Concurrent Medication Had No Concurrent Medication	3099 Participants n=5 Participants
Concurrent Medication Unknown/not reported	3 Participants n=5 Participants
Cautions to Vaccination Had Cautions	169 Participants n=5 Participants
Cautions to Vaccination Had no Cautions	3102 Participants n=5 Participants
History of Vaccination with Measles Vaccine Received the Vaccine	2902 Participants n=5 Participants
History of Vaccination with Measles Vaccine Unknown/not reported	369 Participants n=5 Participants
History of Vaccination with Rubella Vaccine Received the Vaccine	2871 Participants n=5 Participants
History of Vaccination with Rubella Vaccine Unknown/not reported	400 Participants n=5 Participants
History of Vaccination with Measles/Rubella Combined Vaccine Received the Vaccine	351 Participants n=5 Participants
History of Vaccination with Measles/Rubella Combined Vaccine Unknown/not reported	2920 Participants n=5 Participants
Type of Surveying Method after Vaccination Questionnaire, Available	3023 Participants n=5 Participants
Type of Surveying Method after Vaccination Questionnaire, not Available	248 Participants n=5 Participants
Type of Surveying Method after Vaccination Physician's Visit, Yes	653 Participants n=5 Participants
Type of Surveying Method after Vaccination Physician's Visit, No	2618 Participants n=5 Participants
Type of Surveying Method after Vaccination Other, Yes	147 Participants n=5 Participants
Type of Surveying Method after Vaccination Other, No	3124 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Live Attenuated Measles/Rubella Combined Vaccine n=3225 Participants 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.
Number of Participants With Serious Adverse Drug Reactions (ADRs)	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Live Attenuated Measles/Rubella Combined Vaccine n=3225 Participants 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.
Number of Participants With Adverse Drug Reactions (ADRs)	590 Participants

Adverse Events

Live Attenuated Measles/Rubella Combined Vaccine

Serious events: 2 serious events

Other events: 376 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Live Attenuated Measles/Rubella Combined Vaccine n=3225 participants at risk 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.
Nervous system disorders Convulsion	0.03% 1/3225 • Up to Day 28 At each visit the investigator had to document any occurrence of AEs 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 ADRs were collected in this study. Participants may be represented in more than 1 category.
Nervous system disorders Epilepsy	0.03% 1/3225 • Up to Day 28 At each visit the investigator had to document any occurrence of AEs 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 ADRs were collected in this study. Participants may be represented in more than 1 category.

Other adverse events

Other adverse events
Measure	Live Attenuated Measles/Rubella Combined Vaccine n=3225 participants at risk 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.
General disorders Injection site erythema	6.6% 214/3225 • Up to Day 28 At each visit the investigator had to document any occurrence of AEs 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 ADRs were collected in this study. Participants may be represented in more than 1 category.
General disorders Pyrexia	5.0% 162/3225 • Up to Day 28 At each visit the investigator had to document any occurrence of AEs 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 ADRs were collected in this study. Participants may be represented in more than 1 category.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

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