None listed
Conditions
Interventions
Intervention1: NmCV-5: 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 grou
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female 18 through 85 years of age, 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 defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment of the investigator. 5. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 29 visit.
Exclusion criteria
Exclusion criteria: 1. Acute illness, at the time of study vaccine administration (temporary criterion). 2. Recorded fever within 3 days prior to study vaccine administration. 3. History of any meningococcal vaccine administration. 4. Disease caused by N. meningitidis. 5. Household contact with and/or intimate exposure to N. meningitidis infection within 90 days prior 6. H/O severe allergic reactions 7. Impaired/altered function of immune system 8. Contraindication to intramuscular injection or blood draw. 9. Chronic administration of immunosuppressant. 10. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin in the past 3 months. 11. Administration of any vaccine within 28 days prior to enrolment or planned during study 12. Pregnant or breast-feeding. 13. Systemic antibiotic within 3 days prior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To demonstrate the consistency of immune response from three lots of NmCV-5 Timepoint: 28 days post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: To assess the safety and tolerability of study vaccines. Immunogenicity: To assess other immune responses by study vaccines.Timepoint: 28 days after immunization | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Pvt. Ltd.
Outcome results
None listed