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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022803
Receipt No. 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

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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
Email 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
Email fuku789@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital
Travellers' Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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