A Clinical trial to evaluate the safety of measles & Rubella vaccine in healthy child having the age of 9 to 12 months

Phase 4

• Registration Number: CTRI/2022/10/046225
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy paediatric subjects of either sex aged 9 months to 12 months (Age of subject should be at least 9 completed months)

2. Informed consent of either parent (mother or father) and their

willingness to be followed up for at least 6 months after vaccination of

their child

3. Parents with adequate literacy to fill the diary cards

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 / rubella infection or vaccination

with measles / rubella containing vaccine or if they had been exposed# to

measles or rubella virus within 30 days of trial commencement

3. Subjects with a history of convulsions, epilepsy, other central nervous system

diseases, severe disease of hematopoietic system, decompensated heart

disease or impaired renal function

4. Subjects with an acute febrile illness at the time of enrolment

5. Any other vaccine administration within 30 days of initiation of the study

6. A history of serious chronic illness, major congenital defects,

immunosuppression (immunosuppressive illness or therapy)

7. Subjects with any other clinically significant concurrent / past illness for which

the investigator feels that subject should not participate

#Close contact (family member or neighbor) with a diagnosed case of

measles / rubella

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate the safety of Measles & Rubella <br/ ><br>vaccine (Live) I.P. (Freeze Dried) of M/s Zydus Lifesciences Limited in <br/ ><br>subjects aged 9-12 months.Timepoint: The primary objective is to evaluate the safety of Measles & Rubella <br/ ><br>vaccine (Live) I.P. (Freeze Dried) of M/s Zydus Lifesciences Limited in <br/ ><br>subjects aged 9-12 months.

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI