UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011832 |
|---|---|
| Receipt number | 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 17:57:07 |
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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
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
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
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
naon@konan.jaaikosei.or.jp
Sponsor or person
Institute
Konan Kosei Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013832
