UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to investigate the interchangeability between different polio vaccines (OPV, IPV and DPT-IPV) based on immunogenicity and safety
Title of the study (Brief title)	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	Yoshio Hirota
Organization	College of Healthcare Management
Division name	President
Address	960-4, Takayanagi, Setaka-machi, Miyama-shi, Fukuoka, 835-0018
TEL	0944-67-7007
Email	yos-hirota@healthcare-m.ac.jp

Public contact
Name of contact person	Motoki Ishibashi
Organization	PS Clinic, Medical Co. LTA
Division name	Clinical Research Department
Address	6-18, Ten-ya-machi, Hakata-ku, Fukuoka-city, Fukuoka 812-0025
TEL	092-283-7777
Homepage URL
Email	motoki-ishibashi@lta-med.com

Sponsor
Institute	College of Healthcare Management
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 10 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://insights.ovid.com/pubmed?pmid=28591046
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026150