None listed
Conditions
Interventions
Intervention1: Measles and Rubella vaccine (Live) I.P.
(Freeze Dried) of M/s. Zydus Lifesciences Ltd.: Dose:- 0.5 ml
Route:-subcutaneous injection
Frequency :single dose
Duration: Single Dose
Contro
Sponsors
Zydus Lifesciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy infant subject of either sex aged 9 to 12 months at the time of enrollment 2. Subjects should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator 3. No previous history of vaccination against measles and rubella 4. Written informed consent from the subject’s parent (mother/father) 5. Subject’s parent literate enough to fill the diary card 6. Subjects and parents likely to be available for follow-up for entire duration of the study
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reaction to any component of the vaccines 2. History of hypersensitivity reaction to neomycin 3. History of laboratory confirmed or suspected measles or rubella in past 4. History of any vaccination against measles or rubella in past 5. Subject exposed to measles or rubella virus within the past 30 days 6. Fever of any origin or infectious disorder of 3 days or more within the past 30 days 7. Febrile illness (axillary temperature =37.5°C) at the time of enrollment 8. History of any vaccination within the past month 9. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, immunological, metabolic or major congenital disorder 10. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 11. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 12. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 13. Subject participated in another clinical study in the past 3 months 14. Any other reason for which the investigator feels that subject should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Non-inferiority for seropositivity rate for anti-measles and anti-rubella IgG antibodies at 42 days after vaccination between the test group and the reference group 2)Lot-to-lot consistency of 3 batches of the test vaccine at 42 days after vaccination based on geometric mean titre ratioTimepoint: Baseline (Day 0) and Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Seropositivity rate for anti-measles and anti-rubella IgG antibodiesTimepoint: Baseline (Day 0) and End of study (Day 180);Seroconversion rate for anti-measles and anti-rubella IgG antibodiesTimepoint: Baseline (Day 0), Day 42 and End of study (Day 180);Geometric mean titre of anti-measles and anti-rubella IgG antibodiesTimepoint: Baseline (Day 0), Day 42 and End of study (Day 180);Solicited local and systemic adverse eventsTimepoint: Baseline (Day 0) to Day 14;Unsolicited adverse eventsTimepoint: Baseline (Day 0) to End of study (Day 180);Medically attended adverse eventsTimepoint: Baseline (Day 0) to End of study (Day 180);Serious adverse eventsTimepoint: Baseline (Day 0) to End of study (Day 180) | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Zydus Lifesciences Ltd
Outcome results
None listed