| CTRI Number |
CTRI/2024/11/076975 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A study to check immunogenicity and safety of Meningococcal ACYWX Conjugate Vaccine in Healthy Indian Children of 9 months to 17 Years of Age |
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Scientific Title of Study
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A Phase 3, Randomized, Double-blind, Controlled, Multi-Center Study to Compare Immunogenicity and Safety of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) with that of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Indian Children of 9 months to 17 Years of Age |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| ACYWX-05 Version 1.0 Dated 16 May 2024 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Kulkarni MD |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Private Limited (SIIPL) |
| Address |
Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli Poonawalla Road,Hadapsar, Pune - 411028, Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
912071946836 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Prasad Kulkarni MD |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Private Limited (SIIPL) |
| Address |
Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli Poonawalla Road,Hadapsar, Pune - 411028, Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
912071946836 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
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Source of Monetary or Material Support
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| Serum Institute of India Private Limited (SIIPL)
212/2, Hadapsar, Pune - 411028, Maharashtra, India. |
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Primary Sponsor
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| Name |
Serum Institute of India Private Limited (SIIPL) |
| Address |
Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli Poonawalla Road,Hadapsar, Pune - 411028, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
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| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Patil |
Belagavi Institute of Medical Sciences Belagavi |
BIMS Building, 3rd Floor, Clinical Research Department, Near Department of Community Medicine,
Dr BR Ambedkar Road,
Belagavi-590001, Karnataka, India.
Belgaum
KARNATAKA |
9480454944
shaileshpt@yahoo.com |
| Dr Ruby Singh |
Christian Medical College & Hospital |
Department of Pediatrics, CMC Hospital, Brown Road, Ludhiana, Punjab- 141008, India
Ludhiana
PUNJAB |
9815037741
rubyranadive@yahoo.com |
| Dr Shailaja Mane |
Dr. D.Y. Patil Medical College, Hospital and Research Centre |
Department of Pediatrics, Room/OPD Number 12, High-tech Building, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018, India.
Pune
MAHARASHTRA |
9822595553
shailaja.mane@dpu.edu.in |
| Dr Kheya Ghosh Uttam |
Institute of Child Health |
Ground Floor, 11, Dr Biresh Guha Street, Kolkata, West Bengal – 70001, India.
Kolkata
WEST BENGAL |
9830297578
kheya.ghosh.uttam@gmail.com |
| Dr Deepti Thandaveshwara |
JSS Hospital |
Department of Pediatrics, First floor, Room Number - 1083, Ramachandra Agrahara, MG Road, Mysuru, Karnataka- 570004, India.
Mysore
KARNATAKA |
9845023309
deeptiadarsh@gmail.com |
| Dr Anand Kawade |
KEM Hospital Research Centre |
Vadu Rural Health Program - VRHP Department, Ground Floor, Vadu Budruk, Taluka- Shirur, District- Pune 412216
Pune
MAHARASHTRA |
8888891174
anand.kawade@kemhrcvadu.org |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. D. Y. Patil Vidyapeeth |
Approved |
| Institutional Ethics Committee ICH Institute of Child Health |
Approved |
| Institutional Ethics Committee BIMS |
Approved |
| Institutional Ethics Committee Christian Medical College & Hospital |
Approved |
| Institutional Ethics Committee, JSS Medical College JSS Hospital |
Approved |
| KEM Hospital Research Centre Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children between 9 months to 17 years of age |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Menactra® |
The licensed meningococcal serogroups ACYW conjugate vaccine (Menactra®), manufactured by Sanofi Pasteur Inc. Menactra is supplied as a single 0.5 mL ready to use dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 μg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier. |
| Intervention |
NmCV-5 |
The meningococcal vaccine NmCV-5 manufactured by Serum Institute of India Pvt. Ltd. is a pentavalent conjugate vaccine composed of serogroups A, C, Y, W, and X of Neisseria meningitidis. NmCV-5 is provided as the lyophilized powder. The vaccine is reconstituted with 0.5 mL normal saline prior to administration. After reconstitution 0.5 mL of injectable solution of NmCV-5 vaccine will contain 5 µg each of meningococcal serogroups A and X polysaccharides conjugated to tetanus toxoid of 7.8 to 33.4 µg and 5 µg each of meningococcal serogroups C, W and Y polysaccharides conjugated to CRM197 protein of 11.7 to 50.1 µg |
| Comparator Agent |
Placebo |
0.5 mL of 0.9% sodium chloride single use liquid |
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Inclusion Criteria
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| Age From |
9.00 Month(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1.Parent written informed consent.
2.Participants assent (verbal assent for 7 to 11 years old children and written assent for 12 to 17 years old children)
3.Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test
4.Healthy, as determined by medical history and clinical assessment of the investigator.
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| ExclusionCriteria |
| Details |
1.Acute illness
2.H/O meningococcal vaccine administration.
3.History of severe allergic reactions after previous vaccinations or hypersensitivity to tetanus, diphtheria and diphtheria toxoid (CRM197).
4.Any confirmed or suspected condition with impaired/altered function of immune system
5.Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination
6.Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
7.Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines
8.Acute or chronic, clinically significant systemic disorder/disease.
9.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Percentage of participants with seroresponse against each meningococcal serogroup A, C, W, Y and X. |
Cohort 1: Children 9 to 23 months: at Day 29 in NmCV-5 group and at Day 112 in Menactra group.
Cohort 2, Children 2 to 17 years of age: at Day 29 |
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Secondary Outcome
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| Outcome |
TimePoints |
| rSBA Geometric mean titers (GMT) |
Cohort 1: at Days 1, 29 and 112
Cohort 2: at at Days 1 and 29 |
| rSBA titers ≥ 1:8 |
Cohort 1: at Days 1, 29 and 112
Cohort 2: at at Days 1 and 29 |
| rSBA titers ≥ 1:128 |
Cohort 1: at Days 1, 29 and 112
Cohort 2: at at Days 1 and 29 |
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Target Sample Size
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Total Sample Size="810"
Sample Size from India="810"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Neisseria meningitidis is a bacteria responsible for invasive meningococcal disease (IMD), that includes most commonly meningitis and fulminant septicaemia. Pneumonia, myocarditis, or pericarditis may also occur in IMD, though less commonly. Neisseria meningitidis are classified into serogroups based on their capsular polysaccharides. Six of these serogroups viz. A, B, C, W, X, and Y are known to cause majority of IMD cases. To tackle this problem, Serum Institute of India Pvt Ltd has developed meningococcal vaccine NmCV-5 (MenFive) which is a pentavalent conjugate vaccine composed of serogroups A, C, Y, W, and X of Neisseria meningitidis. NmCV-5 is approved for active immunization of individuals aged 18-85 years against invasive meningococcal disease caused by Neisseria Meningitidis serogroups A, C, Y, W, and X in India. WHO has approved NmCV-5 for use in individuals aged 9 months to 85 years. A current Phase 3 study is planned in healthy Indian children aged 9 months to 17 years to demonstrate effective immune responses and safety of NmCV-5 in comparison with the licensed quadrivalent meningococcal conjugate vaccine (MenACWY-D). This study will help to extend the marketing authorization of NmCV-5 for this age group in India.
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