UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034298 |
|---|---|
| Receipt number | R000039102 |
| Scientific Title | Clinical Trial Phase III of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135) |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2018/09/27 19:09:22 |
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Basic information
Public title
Clinical Trial Phase III of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)
Acronym
Evaluation of Safety and Immunogenicity of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)in adult human subjects
Scientific Title
Clinical Trial Phase III of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)
Scientific Title:Acronym
Evaluation of Safety and Immunogenicity of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)in adult human subjects
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Clinical Immunology
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A multicentric, open, controlled and non-comparative clinical trial phase III for Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135) manufactured by M/s Bio Med (P) Ltd., Ghaziabad
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase III
Assessment
Primary outcomes
Evaluation of Reactivity of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)in adult human subjects. Adverse reaction and temperature shall be recorded after 30 minutes, between 4 and 6 hours and again between 24 and 48 hours after injection.
Injection site reaction - pain, erythema, inflammation or any other adverse reaction shall be recorded.
Key secondary outcomes
Evaluation of Immunogenicity of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)in adult human subjects. Evaluation of antibody titer by bactericidal assay.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
As the study was Non Comparative so only test vaccine was given to the subjects and no
control was used
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
| 18 | years-old | <= |
Age-upper limit
| 68 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adult human volunteers above 18 years of age were recruited.
Key exclusion criteria
volunteers suffering from fever,Diarrhoea ,infections and those with history of disease,previous administration ofmeningococcal vaccine,drug intake(except vitamins and immunosuppressants in past two weeks of vaccination date),hypersensitivity to any other component of vaccine were excluded from the study.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Ashish Prakash, |
Organization
Consultant Pediatrics, Yashodha Hospital and research centre
Division name
Pediatrics
Zip code
Address
Yashodha Hospital and research centre, Nehru nagar, Ghaziabad
TEL
0091-120-4157534
ashprakash@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Puneet Garg |
Organization
Bio Med Private Limited
Division name
Research and Development
Zip code
Address
C-96, Site-IV, Bulandshahr Road Industrial Area, Ghaziabad
TEL
0091-120-4204862
Homepage URL
saryugarg@yahoo.com
Sponsor or person
Institute
Bio Med Private Limited
Institute
Department
Personal name
Funding Source
Organization
Bio Med Private Limited
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Indian
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 27 | 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
Results
The Meningococcal Polysacharide Vaccine is safe and welltolerated in subjects 2-3 weeks post vaccination. The antibody titres of the sera from 100% of the subjects showed a fourfold or greator rise in antibody titre of each group (Group A, C, Y and W135) after immunization.
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
Completed
Date of protocol fixation
| 2004 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039102
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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