Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age
NCT ID: NCT04358731
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
1640 participants
INTERVENTIONAL
2019-12-27
2021-03-24
Brief Summary
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A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5.
All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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NmCV-5
A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years.
Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra.
The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5.
Total 1230 subjects will be enrolled in NmCV-5 arm.
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.
The NmCV-5 lyophilized powder component contains sucrose, sodium citrate and trometamol as excipients. This component is presented as a freeze-dried powder in a single dose vial. No preservative or adjuvant is present in the vaccine.
The normal saline diluent is a sterile clear colorless liquid in a single dose glass ampoule.
Menactra
Subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra.
In Menactra arm, total 410 subjects will be enrolled.
Menactra
The control vaccine is the licensed meningococcal serogroups ACYW conjugate vaccine (Menactra), manufactured by Sanofi Pasteur Incorporated. Menactra is supplied as a single 0.5 mL dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier. No preservative or adjuvant is added during manufacture.
Interventions
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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.
The NmCV-5 lyophilized powder component contains sucrose, sodium citrate and trometamol as excipients. This component is presented as a freeze-dried powder in a single dose vial. No preservative or adjuvant is present in the vaccine.
The normal saline diluent is a sterile clear colorless liquid in a single dose glass ampoule.
Menactra
The control vaccine is the licensed meningococcal serogroups ACYW conjugate vaccine (Menactra), manufactured by Sanofi Pasteur Incorporated. Menactra is supplied as a single 0.5 mL dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier. No preservative or adjuvant is added during manufacture.
Eligibility Criteria
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Inclusion Criteria
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 determined by medical history and clinical assessment of the investigator.
5. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
Exclusion Criteria
2. History of any meningococcal vaccine administration.
3. Current or previous, confirmed or suspected disease caused by N. meningitidis.
4. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to vaccination.
5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
18 Years
85 Years
ALL
Yes
Sponsors
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Serum Institute of India Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Prasad Kulkarni, MD
Role: STUDY_DIRECTOR
Serum Institute of India Pvt. Ltd.
Locations
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Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India
Bangalore, Karnataka, India
M S Ramaiah Medical College and Hospitals, Bangalore
Bangalore, Karnataka, India
T. N. Medical College and B. Y. L. Nair Charitable
Mumbai, Maharashtra, India
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, India
Jahangir Clinical Development Centre Pvt. Ltd., Pune
Pune, Maharashtra, India
KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka - Shirur, District - Pune 412216 , Maharashtra Pune
Pune, Maharashtra, India
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
Wardha, Maharashtra, India
Hamdard Institute of Medical Sciences and Research (HIMSR), and Associated Hakeen Abdul Hameed Centenary Hospital (HAHCH) Jamia Hamdard, Hamdard Nagar, New Delhi - 110062
New Delhi, National Capital Territory of Delhi, India
Institute of Medical Sciences and SUM Hospital Bhubaneshwar
Bhubaneshwar, Odisha, India
Sri Ramachandra Institute of Higher Education and Research
Chennai, Tamil Nadu, India
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, , India
Countries
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References
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Kulkarni PS, Kawade A, Kohli S, Munshi R, Maliye C, Gogtay NJ, S RH, Singh K, Vengadakrishnan K, Panigrahi SK, Sahoo J, Bavdekar A, Garg BS, Raut A, Raj JP, Saxena U, Chaudhari VL, Patil R, Venkatarao E, Kumari N, Surendran J, Parulekar V, Gagnon L, Gensale T, Dharmadhikari A, Gairola S, Kale S, Pisal SS, Dhere RM, Mallya A, Poonawalla CS, Kapse D. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study. Lancet Infect Dis. 2025 Apr;25(4):399-410. doi: 10.1016/S1473-3099(24)00576-0. Epub 2024 Nov 6.
Other Identifiers
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ACYWX-04
Identifier Type: -
Identifier Source: org_study_id
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