1,640
Participants
Start Date
December 27, 2019
Primary Completion Date
March 24, 2021
Study Completion Date
March 24, 2021
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.
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
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
T. N. Medical College and B. Y. L. Nair Charitable, Mumbai
Seth G S Medical College & KEM Hospital, Mumbai
Jahangir Clinical Development Centre Pvt. Ltd., Pune, Pune
KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka - Shirur, District - Pune 412216 , Maharashtra Pune, Pune
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram, Wardha
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India, Bangalore
M S Ramaiah Medical College and Hospitals, Bangalore, Bangalore
Sri Ramachandra Institute of Higher Education and Research, Chennai
Institute of Medical Sciences and SUM Hospital Bhubaneshwar, Bhubaneshwar
Serum Institute of India Pvt. Ltd.
INDUSTRY