UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022803 |
|---|---|
| Receipt number | R000026281 |
| Scientific Title | Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2020/12/23 19:36:27 |
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Basic information
Public title
Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years
Acronym
Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years
Scientific Title
Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years
Scientific Title:Acronym
Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years
Region
| Japan |
Condition
Condition
meningococcal disease
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among adults aged >=56 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional meningococcal antibody activity against serogroups A,C,Y,and W-135 antigens
seroprotection to meningococcal antigens (serogroups A,C,Y,and W-135)28 days after vaccination with Meningococcal vaccine
Seroprotection was defined as a post-vaccination titer (>= 1:128) dilution against meningococcal serogroups A,C,Y,and W-135 based on the serum bactericidal assay using baby rabbit complement (SBA-BR)
Key secondary outcomes
Immunogenicity
Meningococcal serogroups A,C,Y,and W-135 antibody titers using the SBA-BR on day 0 before vaccination and on day 28 post-vaccination with the parameters including >=4 fold-rise, geometric mean titers (GMTs)
Safety
any unsolicited systemic adverse events (AEs) reported within 30 minutes after vaccination
solicited injection site reactions
systemic reactions occurring from day 0 through day 7
unsolicited AEs within 28 days after vaccination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Single dose of quadrivalent meningococcal polysaccharide-protein conjugate vaccine
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
| 56 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
Key exclusion criteria
acute febrile illness
immunodeficiency
allergy against vaccine contents
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | SHINJI |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
160-0023
Address
6-7-1 Nishishinjuku shinjuku, Tokyo
TEL
03-3342-6111
fuku789@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | SHINJI |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
160-0023
Address
6-7-1 Nishishinjuku shinjuku, Tokyo
TEL
03-3342-6111
Homepage URL
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Travellers' Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hospital
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
Tokyo Medical University, Institutional Review Board
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel
+81-3-3342-6111
fuku789@tokyo-med.ac.jp
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
東京医科大学病院(東京都)、川崎医科大学付属川崎病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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
23
Results
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026281
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