UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022692 |
|---|---|
| Receipt number | R000026150 |
| Scientific Title | Study to investigate the interchangeability between different polio vaccines (OPV, IPV and DPT-IPV) based on immunogenicity and safety |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2017/06/12 09:41:37 |
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Basic information
Public title
Study to investigate the interchangeability between different polio vaccines (OPV, IPV and DPT-IPV) based on immunogenicity and safety
Acronym
Study of interchangeability between polio vaccines
Scientific Title
Study to investigate the interchangeability between different polio vaccines (OPV, IPV and DPT-IPV) based on immunogenicity and safety
Scientific Title:Acronym
Study of interchangeability between polio vaccines
Region
| Japan |
Condition
Condition
Polio
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the interchangeability among these three types of polio vaccines (OPV, IPV and DPT-IPV)
Basic objectives2
Others
Basic objectives -Others
Immunogenicity, Safety
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the immunogenicity of polio vaccines, geometric mean titer (GMT), fold rise, and seroprotection proportion were calculated.
Key secondary outcomes
To analyze descriptive information on safety (post-vaccination adverse reactions), frequencies of each local and systemic reaction were calculated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
For infants who had received one dose of oral polio vaccine, Doses 2-4 were administered using DPT-IPV.
Interventions/Control_2
For infants who had received one dose of oral polio vaccine and DPT vaccines, Doses 2-4 were administered using IPV.
Interventions/Control_3
For polio vaccine-naive infants, Doses 1-2 were administered using DPT-IPV, and Doses 3-4 were administered using IPV.
Interventions/Control_4
For polio vaccine-naive infants, Doses 1-2 were administered using IPV, and Doses 3-4 were administered using DPT-IPV.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | months-old | <= |
Age-upper limit
| 74 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy infants and children aged 3-74 months without any history of acute poliomyelitis, diphtheria, pertussis, or tetanus.
Key exclusion criteria
Obvious history of anaphylaxis caused by food or drugs; receipt of any live vaccine within the preceding 27 days; receipt of any inactivated vaccine within the preceding 6 days; receipt of any blood transfusion or gamma globulin preparation within the preceding 3 months; receipt of immunosuppressants (except for external use), gamma globulin preparation (200 mg/kg or more), prednisolone (2 mg/kg/day or more) as an adrenocorticosteroid preparation (except for external use), or immunosuppressive therapy (including radiotherapy) within the preceding 6 months; congenital or acquired immunodeficiency; participation in a separate clinical trial (including individuals who had completed a clinical trial in the last 6 months); and individuals who pediatricians deemed ineligible to participate in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Hirota |
Organization
College of Healthcare Management
Division name
President
Zip code
Address
960-4, Takayanagi, Setaka-machi, Miyama-shi, Fukuoka, 835-0018
TEL
0944-67-7007
yos-hirota@healthcare-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoki Ishibashi |
Organization
PS Clinic, Medical Co. LTA
Division name
Clinical Research Department
Zip code
Address
6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka 812-0025
TEL
092-283-7777
Homepage URL
motoki-ishibashi@lta-med.com
Sponsor or person
Institute
College of Healthcare Management
Institute
Department
Personal name
Funding Source
Organization
a research grant for Research on Emerging and Re-emerging Infectious Diseases, Health and Labour Sciences Research Grants from the Ministry of Health, Labor and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sanofi Pasteur S.A.
The Research Foundation for Microbial Diseases of Osaka University
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
医療法人しんどう小児科医院（福岡県）、高崎小児科医院（福岡県）、医療法人横山小児科医院（福岡県）、医療法人やました小児科医院（福岡県）、医療法人しばおクリニック（福岡県）、大阪市立大学大学院医学研究科公衆衛生学（大阪府）、医療法人相生会ピーエスクリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://insights.ovid.com/pubmed?pmid=28591046
Number of participants that the trial has enrolled
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
| 2011 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026150
