| CTRI Number |
CTRI/2019/12/022436 [Registered on: 18/12/2019] Trial Registered Prospectively |
| Last Modified On: |
26/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare different lots of Meningococcal Vaccine and to compare vaccine response with that of other Licensed Meningococcal Vaccine in healthy adults |
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Scientific Title of Study
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A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare its Safety and Immunogenicity with that of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACYWX-04 Version 02 dated 18 September 2019 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
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| Affiliation |
|
| 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 |
| Designation |
Medical Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
02026602384 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Medical Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
02026602384 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
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Source of Monetary or Material Support
|
| Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028 |
|
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Primary Sponsor
|
| Name |
Serum Institute of India Pvt Ltd |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, Hadapsar, Pune 411028 |
| 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
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Kohli |
Hamdard Institute of Medical Sciences and Research (HIMSR) |
Hamdard Institute of Medical Sciences and Research (HIMSR), and Associated Hakeen Abdul Hameed Centenary Hospital (HAHCH)
Jamia Hamdard, Hamdard Nagar, New Delhi – 110062
Centre for Health Research and Development (CHRD), Society for Applied Studies (SAS)
680, Gali No. 5, Nai Basti, Devli Gaon, New Delhi - 110080
New Delhi
DELHI |
011-64788217
sunil.kohli@gmail.com |
| Dr Sandeep Kumar Panigrahi |
Institute of Medical Sciences and SUM Hospital, Bhubaneshwar |
Department of Community Medicine,
Institute of Medical Sciences and SUM Hospital
K8 Kalinganagar, Bhubaneshwar, Orissa – 751003, India
Khordha
ORISSA |
9439369093
sandeeppanigrahi@hotmail.com |
| Dr Kiranjit Singh |
Jahangir Clinical Development Centre Pvt. Ltd. |
Jahangir Clinical Development Centre Pvt. Ltd.,
Jahangir Hospital Premises,
32 Sassoon Road, Pune - 411001, Maharashtra
Pune
MAHARASHTRA |
020-67268800
kiranjitsingh64@gmail.com |
| Dr Anand Kawade |
KEM Hospital Research Centre |
KEM Hospital Research Centre,
Vadu Rural Health Program,
Vadu Budruk, Taluka – Shirur,
District – Pune 412216 , Maharashtra
Pune
MAHARASHTRA |
02137-252234
askawade@yahoo.com |
| Dr Ravish H S |
Kempegowda Institute of Medical Sciences (KIMS), Bangalore |
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram,
Bangalore 560004, Karnataka, India
Bangalore
KARNATAKA |
08026712791
08026712798
drravishhs@rediffmail.com |
| Dr Anil Kumar T |
M S Ramaiah Medical College and Hospitals, Bangalore |
M S Ramaiah Medical College and Hospitals,
M S Ramaiah Nagar, MSRIT Post,
Bangalore – 560054, Karnataka, India
Bangalore
KARNATAKA |
08023600968
buddhatozen4265@gmail.com |
| Dr Chetna Maliye |
Mahatma Gandhi Institute of Medical Sciences, Sewagram |
Department of Community Medicine
Dr Sushila Nair School of Public Health
Mahatma Gandhi Institute of Medical Sciences
Sewagram, Wardha - 442102, Maharashtra, India,
Kasturba Hospital, Sewagram, Wardha
Nagpur
MAHARASHTRA |
07152284341
07152284333
chetnamaliye@mgims.ac.in |
| Dr Madhu Gupta |
Post Graduate Institute of Medical Education and Research (PGIMER) |
Department of Community Medicine & School of Public Health, Post Graduate Institute of Medical Education and Research (PGIMER), Sector-12, Chandigarh - 160 012, India
Chandigarh
CHANDIGARH |
9914208226
madhugupta21@gmail.com |
| Dr Nithya Gogtay |
Seth G S Medical College & KEM Hospital |
Dept. of Clinical Pharmacology,
1st Floor, New Building.
Seth G S Medical College & KEM Hospital,
Parel, Mumbai -400 012, Maharashtra
Mumbai
MAHARASHTRA |
022-24174420
njgogtay@hotmail.com |
| Dr K Vengadakrishnan |
Sri Ramachandra Institute of Higher Education and Research |
Department of General Medicine
Sri Ramachandra Institute of Higher Education and Research (DU), Clinical Research Division, Dental College Basement, No. 1, Ramachandra Nagar, Porur, Chennai – 600116,
Tamil Nadu
Chennai
TAMIL NADU |
044-45928916
drkvk1975@gmail.com |
| Dr Renuka Munshi |
TN Medical College & BYL Nair Hospital |
TN Medical College & BYL Nair Hospital
5th floor, Department of Clinical Pharmacology,
TN Medical College & BYL Nair Hospital, Dr. AL Nair Road, Mumbai Central, Mumbai – 400008, Maharashtra
Mumbai
MAHARASHTRA |
9820377409
renuka.munshi@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee IMS and SUM Hospital |
Approved |
| Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd. |
Approved |
| Ethics Committee M S Ramaiah Medical College and Hospitals |
Approved |
| Institutional Ethics Committee Kempegowda Institute of Medical Sciences |
Approved |
| Institutional ethics committee Mahatma Gandhi Institute of Medical Sciences (MGIMS) |
Approved |
| Institutional Ethics Committee Seth GS Medical College & KEM Hospital |
Approved |
| Institutional Ethics Committee Sri Ramachandra Institute for Higher Education and Research (SRIHER) |
Approved |
| Institutional Ethics Committee Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
Approved |
| Jamia Hamdard Institutional Ethics Committee |
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
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vaccine for meningococcal disease |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mencatra |
Menactra is a solution containing meningococcal A, C, Y, and W polysaccharides conjugated to diphtheria toxoid protein carrier. |
| Intervention |
NmCV-5 |
The NmCV-5 is a fixed-combination available as the lyophilized powder containing meningococcal groups A and X polysaccharides conjugated to tetanus toxoid and meningococcal groups C, W and Y polysaccharides conjugated to CRM197 protein. The vaccine will be reconstituted with normal saline just prior to administration. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or non-pregnant female 18 through 85 years of age, inclusive, at the time of study vaccine administration.
2. Provide written informed consent.
3. The subject is resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study
4. Healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment of the investigator.
5. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 29 visit. |
|
| ExclusionCriteria |
| Details |
1. Acute illness, at the time of study vaccine administration (temporary criterion).
2. Recorded fever within 3 days prior to study vaccine administration.
3. History of any meningococcal vaccine administration.
4. Disease caused by N. meningitidis.
5. Household contact with and/or intimate exposure to N. meningitidis infection within 90 days prior
6. H/O severe allergic reactions
7. Impaired/altered function of immune system
8. Contraindication to intramuscular injection or blood draw.
9. Chronic administration of immunosuppressant.
10. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin in the past 3 months.
11. Administration of any vaccine within 28 days prior to enrolment or planned during study
12. Pregnant or breast-feeding.
13. Systemic antibiotic within 3 days prior. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. To demonstrate the consistency of immune response from three lots of NmCV-5
|
28 days post vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety:
To assess the safety and tolerability of study vaccines.
Immunogenicity:
To assess other immune responses by study vaccines. |
28 days after immunization |
|
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Target Sample Size
|
Total Sample Size="1640"
Sample Size from India="1640"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/12/2019 |
| 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 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in adult Indian subjects between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra). All subjects will receive single dose of either NmCV-5 or Menactra as 0.5 ml IM injection and be followed for 6 months post vaccination. The immune response will be measured in the sera samples collected at Day 0 (pre vaccination) and 28 days post vaccination. Safety will be assessed throughout the study. |