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

Phase 3

Completed

• Conditions: Active immunization for the prevention of disease caused by Measles virus; Encounter for immunization,

• Registration Number: CTRI/2015/05/005739
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This is a randomized, single blind, parallel group, multicentre, non-inferiority phase III clinical trial 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. Three hundred and twenty seven subjects will be randomized to receive either Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited (single-dose or multi-dose vial) or Measles vaccine (Live) (Freeze-dried) of Serum Institute of India Limited according to the centralized computer generated randomization plan. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine antibody titres attained after vaccination using ELISA kit manufactured by IBL International GMBH Germany. A titre >300 Milli International Unit (mIU)/ml will be considered as sero-positive. The primary efficacy end point will be the proportion of subjects who are sero-positive at the end of study in the two groups. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the studyxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-05
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 327

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who are sero-positive at the end of study in the two groups	42 days following vaccination

Secondary Outcome Measures

Name	Time	Method
•Geometric mean titre of anti-measles antibodies in the two groups at the end of the study	42 days following vaccination
•Sero-conversion rate in subjects who were sero-negative before randomization in the two groups at the end of the study	42 days following vaccination

Trial Locations

Locations (7)

Bharati Hospital & Research Centre, Bharati Vidyapeeth; 🇮🇳 Pune, MAHARASHTRA, India

Gandhi General Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

GMERS Medical College & Government Hospital, GOTRI; 🇮🇳 Vadodara, GUJARAT, India

GMERS Medical College and Government Hospital, SOLA; 🇮🇳 Ahmadabad, GUJARAT, India

Indira Gandhi Medical College; 🇮🇳 Shimla, HIMACHAL PRADESH, India

Institute of Child Health; 🇮🇳 Kolkata, WEST BENGAL, India

Mysore Medical College and Research Institute and Associated Hospitals; 🇮🇳 Mysore, KARNATAKA, India

Bharati Hospital & Research Centre, Bharati Vidyapeeth

🇮🇳Pune, MAHARASHTRA, India

Dr Neeta Hanumante

Principal investigator

researchpedpune@gmail.com