Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Biological E s Yellow Fever Vaccine: Each 0.5 mL dose of the vaccine administered intramuscularly on Day 0 and the study duration is 28 days post vaccination.
Intervention2: Biological
Sponsors
Biological E.Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Yellow Fever vaccine-na ve male and the non-pregnant, non-lactating female human volunteers aged between 18 and 45 years of age (both inclusive) at the time of vaccination. 2. Subject, in the opinion of the investigator, has ability to communicate and will comply, with the requirements of the protocol 3.Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject prior to performing any study specific procedure. 4. Subjects considered of stable health as judged by the principal investigator based on personal medical history, protocol specific laboratory parameters and clinical examination findings before entering into the study. 5.Subjects that are negative for Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C by laboratory testing. 6. Negative urine pregnancy test for female subjects of childbearing potential at screening. 7. Female participants of non-childbearing potential.
Exclusion criteria
Exclusion criteria: 1.Individuals with previous history and/or existing laboratory test reports suggesting past infection by a flavivirus such as YF, tick-borne encephalitis (TBE), Japanese encephalitis virus (JE), dengue fever, or West Nile Virus (WNV). 2. Subjects with a travel history to a YF endemic area [Africa or South America including participants who plan to travel to these areas prior to completion of the study]. 3. Individuals with body temperature greater than or equal to 100.4 F within 3 days of intended study vaccine administration. 4. Individuals with any progressive unstable or uncontrolled clinical conditions according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease); 5. Subject inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period; 6. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 7. Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system. 8. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks; 9. Individuals with a history of thymus disorders such as thymoma, myasthenia gravis, and those that are post thymectomy. 10. History of anaphylaxis, allergy, hypersensitivity or allergic reaction to any vaccine-related component; and hypersensitivity to eggs or chicken proteins; 11. Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study; 12. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with solicited local and systemic adverse reactions 2. Proportion of subjects with unsolicited local and systemic adverse events (AEs) 3. Serious adverse events (SAEs) and medically attended adverse events (MAAEs) if any,Timepoint: 1. During first 60 minutes of post vaccination observation period at baseline and for subsequent 10 consecutive days thereafter 2. During the total post vaccination follow up period of 28 days. 3. During the total post vaccination follow up period of 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titres (GMT) of YF neutralizing antibody levelsTimepoint: At baseline, and at Day 28;Proportion of subjects achieving seroconversionTimepoint: at Day 28, post single dose vaccination.;Proportion of subjects achieving seroprotectionTimepoint: at Day 28, post single dose vaccination. | — |
Countries
India
Contacts
Public ContactMr Subba Reddy GV
Biological E.Limited
Outcome results
None listed