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
- Conditions
- Vaccine for Meningococcal Disease
- Interventions
- Biological: NmCV-5Biological: Menactra
- Registration Number
- NCT04358731
- Lead Sponsor
- Serum Institute of India Pvt. Ltd.
- 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 healthy individuals 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).
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1640
- Male or non-pregnant female 18 through 85 years of age, both inclusive, at the time of study vaccine administration.
- Provide written informed consent.
- 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.
- Healthy, as determined by medical history and clinical assessment of the investigator.
- Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
- Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject will be re-revaluated for eligibility).
- History of any meningococcal vaccine administration.
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to vaccination.
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NmCV-5 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. Menactra 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.
- Primary Outcome Measures
Name Time Method Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups 28 days after immunization rSBA assay Geometric Mean Titers (GMTs) at Day 29 against serogroups A, C, W, Y and X in subjects 18 to 29 years of age. 1 month after vaccination
- Secondary Outcome Measures
Name Time Method rSBA GMTs at Days 1 and 29 against serogroups A, C, W, Y and X in pooled NmCV-5# and Menactra vaccine groups. Days 1 and 29
Trial Locations
- Locations (11)
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, Delhi, India
Sri Ramachandra Institute of Higher Education and Research
🇮🇳Chennai, Tamil Nadu, India
M S Ramaiah Medical College and Hospitals, Bangalore
🇮🇳Bangalore, Karnataka, India
Institute of Medical Sciences and SUM Hospital Bhubaneshwar
🇮🇳Bhubaneshwar, Orissa, India
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India
🇮🇳Bangalore, Karnataka, India
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
🇮🇳Wardha, 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
Post Graduate Institute of Medical Education and Research (PGIMER)
🇮🇳Chandigarh, India
T. N. Medical College and B. Y. L. Nair Charitable
🇮🇳Mumbai, Maharashtra, India