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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034298
Receipt No. R000039102
Official scientific title of the study 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

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Basic information
Official scientific title of the study Clinical Trial Phase III of Meningococcal Polysaccharide Vaccine (Group A, C, Y and W135)
Title of the study (Brief title) 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 Dr. Ashish Prakash,
Organization Consultant Pediatrics, Yashodha Hospital and research centre
Division name Pediatrics
Address Yashodha Hospital and research centre, Nehru nagar, Ghaziabad
TEL 0091-120-4157534
Email ashprakash@yahoo.com

Public contact
Name of contact person Dr. Puneet Garg
Organization Bio Med Private Limited
Division name Research and Development
Address C-96, Site-IV, Bulandshahr Road Industrial Area, Ghaziabad
TEL 0091-120-4204862
Homepage URL
Email saryugarg@yahoo.com

Sponsor
Institute Bio Med Private Limited
Institute
Department

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

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

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
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.
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039102

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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