CTRI/2023/05/053120
Active, not recruiting
Phase 3
A Phase III, open label, prospective, multicenter, label expansion study to evaluate safety and immunogenicity of Inactivated Japanese Encephalitis Vaccine (JEEV™) in 49-70 years old adults and in the healthy 9-12 months old infants either alone or when co-administered with a licensed MMR vaccine at 9 months of age. - None
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Sponsor
- Biological E.Limited
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria for Age Group – I:
- •1\. Healthy infants of either gender between 9 months to 12 months of age at the time of enrolment:
- •o\=9 \- 12 months at the time of enrolment in sub\-group\-1,
- •o\=9 months (\+15 days time window) at the time of enrolment in sub\-group\-2 and sub group\-3
- •2\.Residence in the study area.
- •3\. Parent or guardian willing to provide written informed consent.
- •4\. Generally healthy and free of obvious health problems as established by medical history, physical examination, and clinical judgment by the investigator.
- •5\. Parent or guardian is willing to attend all planned study visits and allow home visits and phone contacts, as required by the protocol.
- •Inclusion Criteria for Age Group \- II:
- •1\. Male or female subjects \= 49 to 70 years of age at the time of 1st vaccination of good general health status including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, cardiovascular disease or non\-insulin dependent diabetes mellitus.
Exclusion Criteria
- •Exclusion Criteria for Age Group – I:
- •1\. Previous receipt of any measles\-mumps\-rubella containing vaccine (Exclusion for Sub Group II \& III only under Group\-I).
- •2\. Previous receipt of any Japanese encephalitis vaccine.
- •3\.History of measles, mumps, rubella, or Japanese encephalitis infection.
- •4\.Administration of any other vaccine within 28 days prior to administration of a study vaccine or planned vaccination of any vaccine other than catch\-up doses of routine EPI vaccines or oral polio vaccine during the 28 days after study vaccination.
- •5\. Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the study period.
- •Exclusion Criteria for Age Group – II:
- •1\. History of clinical manifestation of any flavivirus infection (Yellow Fever, Dengue Fever, JE, Tick Borne Encephalitis (TBE) and West e Fever/Neuroinvasive Disease (Neuroinvasive disease is defined as organism infecting or capable of infecting the nervous system and especially the central nervous system);
- •2\. Vaccination against JE, Yellow fever, Dengue Fever or West e Fever at any time prior or during the study;
- •3\. Vaccination against Tick Borne Encephalitis (TBE) within 30 days prior to first dose of JEEV vaccination at Visit 1 (Day 0\);
Outcomes
Primary Outcomes
Not specified
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