Status:
COMPLETED
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
Lead Sponsor:
Serum Institute of India Pvt. Ltd.
Conditions:
Vaccine for Meningococcal Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
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 N...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2021
Estimated Enrollment :
1640 Patients enrolled
Trial Details
Trial ID
NCT04358731
Start Date
December 27 2019
End Date
March 24 2021
Last Update
September 8 2021
Active Locations (11)
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1
Kempegowda Institute of Medical Sciences (KIMS) Hospital & Research Centre, K. R. Road, V. V. Puram, Bangalore 560004, Karnataka, India
Bangalore, Karnataka, India, 560004
2
M S Ramaiah Medical College and Hospitals, Bangalore
Bangalore, Karnataka, India, 560054
3
T. N. Medical College and B. Y. L. Nair Charitable
Mumbai, Maharashtra, India, 400008
4
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, India, 400012