A clinical study to assess the safety and immunogenicity of Japanese Encephalitis vaccine of BE in 9 to 12 months old infants and in 49-70 year old adults
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2023/05/053120
- Lead Sponsor
- Biological E.Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
2. Written informed consent obtained from the subject prior to any study related procedures
3. White blood cells =2,500/mm3 and <11,000/mm3 at Visit 1 Screening & Enrollment Visit)
4. Absolute neutrophil count within normal limits at Visit 1 (Screening & Enrollment Visit)
5. Platelets within normal limits at Visit 1 (Screening & Enrollment Visit)
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);
4.Use of any other investigational or non-registered medicinal product within 30 days prior to JEEV vaccination at Visit 1 (Day 0) and throughout the entire study period;
5. Known history of Infection with the human immunodeficiency virus (HIV), Hepatitis B virus (HBV, Hepatitis B surface antigen [HBsAg]) or Hepatitis C virus (HCV).
5. Periodic steroid injections, e.g., intra-articular, are not allowed within 30 days prior to first JEEV vaccination at Visit 1 (Day 0) and during study period;
6. History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded;
7. Acute febrile infections or exacerbation of chronic infection on the day of JEEV vaccination (Day 0 and Day 28);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of subjects with solicited adverse reactions. <br/ ><br>2.Proportion of subjects with unsolicited local and systemic adverse events (AEs) during the subsequent follow up period. <br/ ><br>3.Serious adverse events (SAEs), medically attended AEs and AEs of special interest, if any.Timepoint: 1.during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days. <br/ ><br>2.until 28 days after last dose <br/ ><br>3.during the post vaccination follow up period until 28 days after last dose.
- Secondary Outcome Measures
Name Time Method Geometric mean concentrations, seroconversion rates (%) and =4-fold rise of anti-Measles, anti-Mumps and anti-Rubella IgG antibodiesTimepoint: At day 28 from baseline;Geometric mean titres, seroconversion rates (%) and proportion of subjects with =4-fold rise of anti-JEV neutralising antibodiesTimepoint: At day 56 i.e., 28 days’ post 2nd dose from baseline;Non-inferiority of JEEV vaccine in terms of 95% CI for ratio of geometric means when co-administered with MMR vaccineTimepoint: At 28 days after the last dose;Non-inferiority of MMR vaccine antigens in terms of 95% CI for difference in seroconversion rates when co-administered with JEEV vaccineTimepoint: At 28 days after the last dose