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Recruitment status Completed
Unique ID issued by UMIN UMIN000011832
Receipt No. R000013832
Scientific Title A study about immunogenicity and safety of Phase 3 and 4 immunization with combined measles-rubella vaccine
Date of disclosure of the study information 2013/09/23
Last modified on 2013/09/22

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Basic information
Public title A study about immunogenicity and safety of Phase 3 and 4 immunization with combined measles-rubella vaccine
Acronym A study about immunogenicity and safety of Phase 3 and 4 immunization with MR vaccine
Scientific Title A study about immunogenicity and safety of Phase 3 and 4 immunization with combined measles-rubella vaccine
Scientific Title:Acronym A study about immunogenicity and safety of Phase 3 and 4 immunization with MR vaccine
Region
Japan

Condition
Condition measles and rubella
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A two phase measles-rubella combined vaccine (MR) immunization schedule (age 1 and prior to primary school entry) was introduced in Japan in April 2006. Furthermore, to carry out two dose immunization to a youth of around 20 years old, other immunizations in 13-year-old cohort (Phase 3) and 18-year-old cohort (Phase 4) were introduced for the 5 year period April 2008 to March 2013. We performed this study to review the immunogenicity and safety of the Phase 3 and Phase 4 MR immunization.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Measles HI and NT antibody positive rates and mean titers before and 4-6 weeks after Phase 3 and Phase 4 MR immunization, and rubella HI antibody positive rates and mean titers before and 4-6 weeks after the both immunization.
2) Before and after the both MR immunization, comparison of the antibody positive rates and the mean antibody titers.
3) Incidence of clinical reactions for 4 weeks after the both MR immunization.
4) Morbidity of measles and rubella after the both immunization.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
12 years-old <=
Age-upper limit
19 years-old >
Gender Male and Female
Key inclusion criteria Healthy children or adolescents with an agreement of a guardian on this study, who received Phase 3 or Phase 4 MR immunization at the pediatric outpatient clinic of Konan Kosei Hospital in Japan, from Feb 2008 to Oct 2012.
Key exclusion criteria We exclude the subjects from whom we could not obtain the paired serum samples (before and 4-6 weeks after the immunization).
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Ozaki
Organization Konan Kosei Hospital
Division name Department of Pediatrics
Zip code
Address 137 Ohmatsubara Takaya-cho, Konan, Aichi
TEL 0587-51-3333
Email takao-oz@konan.jaaikosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Nishimura
Organization Konan Kosei Hospital
Division name Department of Pediatrics
Zip code
Address 137 Ohmatsubara Takaya-cho, Konan, Aichi
TEL 0587-51-3333
Homepage URL
Email naon@konan.jaaikosei.or.jp

Sponsor
Institute Konan Kosei Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 江南厚生病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We will present the results at the 17th annual meeting of the Japanese Society for Vacccinology on November 30, 2013.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 07 Day
Last follow-up date
2013 Year 09 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2013 Year 09 Month 22 Day
Last modified on
2013 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013832


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