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

Measles/Rubella Clinical Trial

Official title:

Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Specified Drug-use Survey of Vaccinees After the Second Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158364
• Other study ID #: 247-012
• Secondary ID: JapicCTI- 142507
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: January 30, 2018
• Start date: March 28, 2007
• Est. completion date: February 20, 2011

Study information

• Verified date: January 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3331
• Est. completion date: February 20, 2011
• Est. primary completion date: February 20, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Measles
• Measles/Rubella
• Rubella

Intervention

Drug:
• 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 (Schwarz FF-8 strain/TO-336 strain)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to Day 28
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.	Up to Day 28