UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013551 |
|---|---|
| Receipt number | R000015830 |
| Scientific Title | Immunogenicity and safety of booster doses of the inactivated polio vaccine |
| Date of disclosure of the study information | 2014/03/28 |
| Last modified on | 2023/01/01 20:02:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Immunogenicity and safety of booster doses of the inactivated polio vaccine
Acronym
Immunogenicity and safety of booster doses of the inactivated polio vaccine
Scientific Title
Immunogenicity and safety of booster doses of the inactivated polio vaccine
Scientific Title:Acronym
Immunogenicity and safety of booster doses of the inactivated polio vaccine
Region
| Japan |
Condition
Condition
Polio
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is evaluate immunogenicity and safety of two booster doses of eIPV in Japanese adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Neutralizing antibody titer of poliovirus
Key secondary outcomes
Adverse event
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
Two booster doses of inactivated poliovaccine
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
acute febrile illness
immunodeficiency
allergy against vaccine contents
pregnancy
Target sample size
100
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 shinjukuku, 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 shinjukuku, Tokyo
TEL
03-3342-6111
Homepage URL
http://hospinfo.tokyo-med.ac.jp/shinryo/tokou/
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Shinji Fukushima
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Infectious Diseases
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical University Hospital
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
IRB@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)、国立感染症研究所(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/vaccines10122160
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/vaccines10122160
Number of participants that the trial has enrolled
62
Results
Before vaccination, the seropositivity rates were as follows: Sabin 1 (88.5%), Sabin 2 (95.1%), Sabin 3 (52.5%), Mahoney (72.1%), MEF-1 (93.4%), Saukett (31.1%), SV3128 (93.4%), SV3130 (93.4%), 11196 (93.4%), and 11198 (88.5%).
The seropositivity rates after the first dose were as follows: Sabin 1 (98.4%), Sabin 3 (98.4%), Mahoney (98.4%), Saukett (98.4%) and others (100%).
The second dose resulted in 100% seropositivity rates against all po-liovirus strains tested.
Results date posted
| 2023 | Year | 01 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixty two participants were enrolled in this study, but .
In total, 61 participants comprised 26 men and 35 women with a mean age of 35.8 years.
Thirty-seven participants had received two doses of primary tOPV in childhood, and two participants had received one dose of tOPV.
One participant was unvaccinated with tOPV.The number of tOPV doses for twenty-one participants was unknown because they had not kept their immunization records.
Participant flow
On their first visit, each participant received blood sampling and the first dose of cIPV vaccination after their eligibility was confirmed.
Visit 2 was for blood sampling and a second vaccination of cIPV and Visit 3 was for blood sampling.
The second and third visits occurred between 4 and 6 weeks following the previous visit.
Adverse events
No severe adverse events
Outcome measures
Immunogenicity was assessed by measuring serum neutralization titers against type 1, 2, and 3 polioviruses in HEp-2 cells using a microneutralization assay.
Viruses included Sabin strains (type 1, 2, and 3), virulent poliovirus strains (type 1: Ma-honey strain; type 2: MEF-1 strain; and type 3: Saukett strain), and type 2 VDPVs derived from sporadic cases of acute flaccid paralysis in Vietnam in 2012 (SV3128 and SV3130) and cases from an outbreak in Nigeria in 2005 (11196 and 11198).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | 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
| 2014 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015830
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
