Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vaccine for Meningococcal Disease
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 1640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female 18 through 85 years of age, both 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 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:

1. 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).
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).

Primary outcomes:
measure: 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.
timeFrame: 1 month after vaccination
measure: Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups
timeFrame: 28 days after immunization
Secondary outcomes:
measure: rSBA GMTs at Days 1 and 29 against serogroups A, C, W, Y and X in pooled NmCV-5# and Menactra vaccine groups.
timeFrame: Days 1 and 29
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Hamdard Institute of Medical Sciences and Research (HIMSR), and Associated Hakeen Abdul Hameed Centenary Hospital (HAHCH) Jamia Hamdard, Hamdard Nagar, New Delhi - 110062
state: Delhi
city: Bangalore
country: India
facility: Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India
state: Karnataka
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospitals, Bangalore
state: Karnataka
city: Mumbai
country: India
facility: T. N. Medical College and B. Y. L. Nair Charitable
state: Maharashtra
city: Mumbai
country: India
facility: Seth G S Medical College & KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Jahangir Clinical Development Centre Pvt. Ltd., Pune
state: Maharashtra
city: Pune
country: India
facility: KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka - Shirur, District - Pune 412216 , Maharashtra Pune
state: Maharashtra
city: Wardha
country: India
facility: Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
state: Maharashtra
city: Bhubaneshwar
country: India
facility: Institute of Medical Sciences and SUM Hospital Bhubaneshwar
state: Orissa
city: Chennai
country: India
facility: Sri Ramachandra Institute of Higher Education and Research
state: Tamil Nadu
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research (PGIMER)
Study officials:
affiliation: Serum Institute of India Pvt. Ltd.
name: Dr Prasad Kulkarni, MD
role: STUDY_DIRECTOR
References: