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

An active post-marketing surveillance study to evaluate the safety of Measles & Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Zydus Lifesciences Limited in healthy subjects aged 9-12 months

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/10/046225

Enrollment

1900

Registered

2022-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

None listed

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Jayesh Sanmukhani

Zydus Lifesciences Limited

r.mittal@zyduslife.com079-48041430

Outcome results