None listed
Conditions
Interventions
Intervention1: Measles, Mumps and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s.
Zydus Lifesciences Ltd. [single-dose and multi-dose formulations]: Dose : 0.5 ml
Frequency : Single dose
Duration
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy infant participant of either gender aged 9 to 12 months at the time of enrollment 2. Participants 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, mumps, and rubella 4. Written informed consent from the participants parent (mother or father) 5. Participant parent literate enough to fill the diary card 6. Participants and parents likely to be available for follow-up for entire duration of the study
Exclusion criteria
Exclusion criteria: 1. Participant s weight (Z-score) below -2 SD for weight-for-age as per WHO recommended child growth standards 2. History of hypersensitivity reaction to any component of the vaccines 3. History of hypersensitivity reaction to neomycin, gelatin or albumin 4. History of hypersensitivity to egg proteins. 5. History of laboratory confirmed or suspected measles, mumps or rubella in past 6. Participant exposed to measles, mumps or rubella virus within the past 30 days 7. Fever of any origin or infectious disorder of 3 days or more within the past 30 days 8. Febrile illness (axillary temperature greater than equal to 37.5 C) at the time of enrollment 9. History of any vaccination within the past month 10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, immunological, metabolic or major congenital disorder 11. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 12. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy. 13. Participants administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 14. Participation in any clinical study in the past 3 months 15. Any other reason for which the investigator feels that participant should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Non-inferiority for seropositivity rate for anti-measles, anti-mumps and antirubella IgG antibodies at 42 days after vaccination between the test group and the reference group 2) Non-inferiority for seroconversion rate for anti-measles, anti-mumps and antirubella IgG antibodies at 42 days after vaccination between the test group and the reference group 3)Lot-to-lot consistency of 3 batches of the test vaccine at 42 days after vaccination based on geometric mean titre ratio 4)Geometric mean titre of anti-measles, anti-mumps and anti-rubella IgG antibodies at 42 days after vaccination in the test group and the reference groupTimepoint: 1) Day 42 2) Day 42 3) Day 42 4) Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Solicited local and systemic adverse events reported during the studyTimepoint: Baseline to Day 14;Unsolicited adverse events reported during the studyTimepoint: Baseline to Day 180;Medically attended adverse events reported during the studyTimepoint: Baseline to Day 180;Serious adverse events reported during the studyTimepoint: Baseline to Day 180 | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani MD
Zydus Lifesciences Limited
Outcome results
None listed