Study to examine immune response and safety of Zyvac MMR vaccine

A prospective, randomized, parallel, single-blind, two-arm, active-controlled, multicentre, phase IV clinical trial to evaluate the immunogenicity and safety of Measles, Mumps, and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd. compared to Measles, Mumps, and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089085

Enrollment

720

Registered

2025-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Measles, Mumps and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd.: Dose: 0.5 ml Duration: 180 days Frequency of administration: Two times Control Interventi

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 subjects parent (mother/father) 5. Participants 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 Age calculated as per completed months

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity reaction to any component of the vaccines 2. History of hypersensitivity reaction to neomycin, gelatin or albumin 3. History of hypersensitivity to egg proteins. 4. History of laboratory confirmed or suspected measles, mumps or rubella in past 5. Subject exposed to measles, mumps 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 greater than or equals to 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. Participants administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 13. Subject participated in any clinical study in the past 3 months 14. Any other reason for which the investigator feels that subject should not participate Close contact (family member or neighbour) with laboratory confirmed or clinical diagnosis of measles / mumps / rubella

Design outcomes

Primary

Measure	Time frame
To evaluate the immunogenicity of MMR vaccine of M/s. Zydus Lifesciences Ltd. compared to MMR vaccine of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 monthsTimepoint: At Day 0, weeks 6, weeks 26, weeks 32	—

Secondary

Measure	Time frame
To evaluate the safety of MMR vaccine of M/s. Zydus Lifesciences Ltd. compared to MMR vaccine of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 monthsTimepoint: At Day 0, weeks 2, weeks 6, weeks 26, weeks 28, weeks 32	—

Countries

India

Contacts

Public ContactMr Mayur Vichhwawala

Cliantha Research Limited

ajadav@cliantha.com9909010714

Outcome results