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
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
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.
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).