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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,640

Participants

Timeline

Start Date

December 27, 2019

Primary Completion Date

March 24, 2021

Study Completion Date

March 24, 2021

Conditions
Vaccine for Meningococcal Disease
Interventions
BIOLOGICAL

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."

BIOLOGICAL

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.

Trial Locations (11)

110062

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

160012

Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh

400008

T. N. Medical College and B. Y. L. Nair Charitable, Mumbai

400012

Seth G S Medical College & KEM Hospital, Mumbai

411001

Jahangir Clinical Development Centre Pvt. Ltd., Pune, Pune

412216

KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka - Shirur, District - Pune 412216 , Maharashtra Pune, Pune

442102

Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram, Wardha

560004

Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India, Bangalore

560054

M S Ramaiah Medical College and Hospitals, Bangalore, Bangalore

600116

Sri Ramachandra Institute of Higher Education and Research, Chennai

751003

Institute of Medical Sciences and SUM Hospital Bhubaneshwar, Bhubaneshwar

All Listed Sponsors
lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT04358731 - 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 | Biotech Hunter | Biotech Hunter