None listed
Conditions
Interventions
Intervention1: MMRV vaccine: Dose:0.5 mL
Route:Subcutaneous
Duration:once
Frequency:Single
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male and non-pregnant, non-lactating female participants aged between 18 and 50 years (Both inclusive). 2)Body weight greater than 50 kg for male and greater than 45 kg for female and BMI within the range 18.5 to 30.0 kg/m2 (Both inclusive). 3)Ability to communicate effectively with study personnel. 4)Willingness to adhere to the protocol requirements. 5)Be able to give written informed consent for participation in the trial. 6.Normal health as determined by personal medical/surgical history, vaccination history, vital signs, physical examination, Chest X-ray PA view (only if clinically indicated), ECG and laboratory assessment data during screening (within the clinically acceptable range). 7.Male participants must agree to use effective contraception till study completion. 8.Female participants of childbearing potential must agree to use effective contraception till study completion. 9.Participant should be literate enough to understand study requirements and fill the diary card.
Exclusion criteria
Exclusion criteria: 1. Participants with known hypersensitivity to any component of the study vaccine 2. History of any hypersensitivity reaction, anaphylaxis or serious reactions to egg proteins, neomycin, albumin, gelatin or gelatin containing product. 3. Participants who are taking immunostimulant therapy (e.g., interferons) or immunosuppressant medications (e.g., corticosteroids, cytotoxic drugs or antimetabolites, etc.). 4. Participants who are known to be suffering from diseases which can affect immune competence e.g., diabetes, immunodeficiency disorders or known to be HIV positive. 5. Participants who have received immunoglobulins parenterally during the preceding 3 months of screening. 6. Participants who have received any vaccine in the preceding 1 month and who are planning to take vaccine during study period. 7. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, gynecological or any other body system involvement which interferes with safety assessment as per investigator discretion. 8. History or presence of significant alcoholism or drug abuse within the past one-year. 9. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product. 10. Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg. 11. Pulse less than 60/minute or more than 100/minute. 12. History of fever or any other infection in last 2 weeks of enrolment 13. Any clinically significant ECG abnormalities at screening. 14. Any clinically significant abnormal laboratory values during screening. 15. Participants who have participated in clinical research studies within past 3 months. 16. History of Blood donation or receipt of blood-derived products (e.g. plasma) within past 3 months prior to screening. 17. A positive urine drugs of abuse test or positive alcohol test at check-in. 18. For female participants, positive serum -hCG level at screening or urine pregnancy test at check-in visit. 19. Female participants with history of pregnancy or lactation in the past 3 months. 20. Female participants with history of less than 1 year of menopause and not using adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Solicited local and systemic adverse events reported during the study 2)Unsolicited adverse events reported during the study 3)Serious adverse events reported during the studyTimepoint: Baseline to Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Seropositivity rate for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodiesTimepoint: at baseline and day 42;Geometric mean titre of anti- measles, anti-mumps, anti-rubella and anti-varicella antibodiesTimepoint: at baseline and day 42 | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani MD
Zydus Lifesciences Limited
Outcome results
None listed