Back to resultsStudy 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 (ACYWX-04)
Primary Purpose
Vaccine for Meningococcal Disease
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
NmCV-5
Menactra
Sponsored by
About this trial
This is an interventional prevention trial for Vaccine for Meningococcal Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Hamdard Institute of Medical Sciences and Research (HIMSR), and Associated Hakeen Abdul Hameed Centenary Hospital (HAHCH) Jamia Hamdard, Hamdard Nagar, New Delhi - 110062
- Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India
- M S Ramaiah Medical College and Hospitals, Bangalore
- T. N. Medical College and B. Y. L. Nair Charitable
- Seth G S Medical College & KEM Hospital
- Jahangir Clinical Development Centre Pvt. Ltd., Pune
- KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka - Shirur, District - Pune 412216 , Maharashtra Pune
- Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
- Institute of Medical Sciences and SUM Hospital Bhubaneshwar
- Sri Ramachandra Institute of Higher Education and Research
- Post Graduate Institute of Medical Education and Research (PGIMER)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NmCV-5
Menactra
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups
Secondary Outcome Measures
rSBA GMTs at Days 1 and 29 against serogroups A, C, W, Y and X in pooled NmCV-5# and Menactra vaccine groups.
Full Information
NCT ID
NCT04358731
First Posted
April 20, 2020
Last Updated
September 4, 2021
Sponsor
Serum Institute of India Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04358731
Brief Title
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
Acronym
ACYWX-04
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serum Institute of India Pvt. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccine for Meningococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1640 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NmCV-5
Arm Type
Experimental
Arm Description
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.
Arm Title
Menactra
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
NmCV-5
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Menactra
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
1 month after vaccination
Title
Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups
Time Frame
28 days after immunization
Secondary Outcome Measure Information:
Title
rSBA GMTs at Days 1 and 29 against serogroups A, C, W, Y and X in pooled NmCV-5# and Menactra vaccine groups.
Time Frame
Days 1 and 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Prasad Kulkarni, MD
Organizational Affiliation
Serum Institute of India Pvt. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Hamdard Institute of Medical Sciences and Research (HIMSR), and Associated Hakeen Abdul Hameed Centenary Hospital (HAHCH) Jamia Hamdard, Hamdard Nagar, New Delhi - 110062
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110062
Country
India
Facility Name
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560004
Country
India
Facility Name
M S Ramaiah Medical College and Hospitals, Bangalore
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
T. N. Medical College and B. Y. L. Nair Charitable
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Seth G S Medical College & KEM Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Jahangir Clinical Development Centre Pvt. Ltd., Pune
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka - Shirur, District - Pune 412216 , Maharashtra Pune
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
412216
Country
India
Facility Name
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
City
Wardha
State/Province
Maharashtra
ZIP/Postal Code
442102
Country
India
Facility Name
Institute of Medical Sciences and SUM Hospital Bhubaneshwar
City
Bhubaneshwar
State/Province
Orissa
ZIP/Postal Code
751003
Country
India
Facility Name
Sri Ramachandra Institute of Higher Education and Research
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Facility Name
Post Graduate Institute of Medical Education and Research (PGIMER)
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
After one year of study completion
Learn more about this trial
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
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