Clinical study to compare the immune response and safety of Measles vaccine manufactured by Cadila healthcare Ltd. with Measles vaccine manufactured by Serum Institute of India Ltd. in children 9-12 months of age

A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority, phase III clinical study to evaluate the immunogenicity and safety of single-dose and multi-dose vials of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to Measles vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/05/005739

Enrollment

327

Registered

2015-05-05

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: Single-dose vial of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited: Each subject will be given a single dose of 0.5ml vaccine from single dose vial given as a su

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy paediatric subjects of either sex aged 9 months to 12 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 other vaccines, gelatin and / or albumin 2.Subjects with a history of previous measles infection or measles vaccination or if they had been exposed# to measles virus within 30 days of trial commencement 3.Subjects with a history of convulsions, epilepsy, other central nervous system diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function 4.Subjects with an acute febrile illness at the time of randomization 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, blood products or immunoglobulins during the preceding 3 months 8.Subjects with any other clinically significant concurrent illness affecting immune response after vaccination

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who are sero-positive at the end of study in the two groupsTimepoint: 42 days following vaccination	—

Secondary

Measure	Time frame
â?¢ Geometric mean titre of anti-measles antibodies in the two groups at the end of the studyTimepoint: 42 days following vaccination;â?¢ Sero-conversion rate in subjects who were sero-negative before randomization in the two groups at the end of the studyTimepoint: 42 days following vaccination	—

Countries

India

Contacts

Public ContactDr Jayesh Sanmukhani

Cadila Healthcare Ltd

r.mittal@zyduscadila.com079-26868926

Outcome results

None listed

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