Clinical Study to assess the immune response and safety of Measles, Mumps and Rubella (MMR) vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 15-18 months

A randomized, open label, multicentric, phase II clinical trial to assess the immunogenicity and safety of Measles, Mumps and Rubella (MMR) vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 15-18 months - None

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004339

Enrollment

100

Registered

2014-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Measles, Mumps and Rubella vaccine (Live)-Single dose (Freeze-dried) of M/s Cadila Healthcare Ltd.

Measles, Mumps and Rubella vaccine (Live)-Multi dose (Freeze-dried) of M/s Cadila Healthcare Ltd.: Each subject will be given a single dose of 0.5ml vaccine from single dose vial given as a subcutaneo

Each subject will be given a single dose of 0.5ml vaccine from multidose vial given as a subcutaneous injection in the upper arm on 0 day. Intervention2: Measles, Mumps and Rubella vaccine (Live)-Mult

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy pediatric subjects of either sex aged 15 months to 18 months. 2.Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child. 3.Parents/guardians with adequate literacy to fill the diary cards

Exclusion criteria

Exclusion criteria: 1.Subjects with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to neomycin. 2.Subjects with a history of previous measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement. 3.Subjects having received measles vaccine less than 3 months back. 4.A history of convulsions, epilepsy or other central nervous system diseases or an acute febrile illness at the time of planned vaccination. 5.Any other parenteral vaccine administration within 30 days of initiation of the study or during the study. 6.A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy). 7.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months. 8.Subjects with any other clinically significant concurrent illness.

Design outcomes

Primary

Measure	Time frame
The primary immunogenicity criteria will be the seroconversion rate for measles, mumps and rubellaTimepoint: 42 days following vaccination	—

Secondary

Measure	Time frame
The secondary immunogenicity criteria will be the post-vaccination geometric mean titers (GMTs) of antibodies to measles, mumps and rubellaTimepoint: 42 days following vaccination	—

Countries

India

Contacts

Public ContactDr Jayesh Sanmukhani

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026