Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Inactivated vero-cell based Japanese encephalitis vaccine of BE LTD: 3µ
g/0.25mL dose administered intramuscularly on 0 and 28th day
Control Intervention1: Inactivated Mouse-brain derived Japanese encephalitis vaccine of Kroean Greencross Corporation, Korea: 0.5mL per dos
Sponsors
Biological E Limited AzamabadHyderabad AP India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy subjects of either sex in the age group of greater than or equal to 1 to < 3 years at the time of 1st vaccination. 2.Free of significant health problems as established by medical history and clinical laboratory tests before entering into the study. 3.Written informed consent obtained prior to screening from subject's parent or legally acceptable representative/guardian. 4.Ability of the subject's parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1.No written informed consent due to Inability or unwillingness either from subjects parent or legal representative or guardian. 2.Known exposure or history of clinical manifestation of either Japanese encephalitis, Dengue or yellow fever. 3.History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever. Note: Measles vaccinated children will be included into the study. 4.Inability or unwillingness to abide by the requirements of the study 5.Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. 6.Planned administration of a vaccine which is not included in the WHO/EPI/UIP schedule during the study period. 7.Any family history of Immunodeficiency or autoimmune disease 8.History of administration of chronic (defined as more than 14 days) immuno-suppressants or other immune-modifying drugs up to six months prior to vaccination (Topical steroids, not inhaled, allowed). 9.History of severe hypersensitivity reactions (in particular to a component of the investigational vaccine, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission). 10.Any confirmed or suspected Infection with HIV, Hepatitis B (HBsAg) or Hepatitis C. 11.Subjects with history of type-I diabetes, severe cardiopulmonary disorders, hepatobiliary / renal disorders and malignancy 12.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Solicited local and systemic adverse events (AEs). 2.Solicited and unsolicited local and systemic adverse events (AEs). 3.All vital signs (Pulse, axillary body temperature and Respiratory rate) for any clinically significant changes. Timepoint: 1)During first 60 minutes post vaccination 2)During subsequent period of 7 days through subject diary and upto day 56 3)once at baseline and again at each scheduled visit.;1.Solicited local and systemic adverse events (AEs). 2.Solicited and unsolicited local and systemic adverse events (AEs). 3.All vital signs (Pulse, axillary body temperature and Respiratory rate) for any clinically significant changes. Timepoint: 1)During first 60 minutes post vaccination 2)During subsequent period of 7 days through subject diary and upto day 56 3)once at baseline and again at each scheduled visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of subjects seroconverted in both the vaccine groups. 2.Proportion of subjects achieving 4- fold rise in anti- JEV neutalising antibody titres. 3.Geometric mean titres for serum dilution giving a 50% reduction in JEV- Plaque counts in a plaque reduction neutralization test. 4.Rate of SAEs and medically attended AEs. 5.All safety laboratory parameters (Haemotology and serum chemistry) for any clinically significant changes.Timepoint: 1.At day 28 in both vaccine groups. 2.At day 28 and day 56 in both vaccine groups. 3.At day 28 and day 56. 4.After the first vaccination until day 56. 5.At baseline visit and day 56. | — |
Countries
India
Contacts
Public ContactMr Pawan Bhusari
Biological E. Limited
Outcome results
None listed