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Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children | Clinical Trials | Clareo Health

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Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children

A Phase IV, Non-Inferiority, Observer Blind Randomized Clinical Study Comparing Safety And Immunogenicity Of MMR Subcutaneous Vaccination By Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe For The Administration In Healthy Children In India Aged 15 To 18 Months

NCT02253407•Serum Institute of India Pvt. Ltd.

View on ClinicalTrials.gov

Summary

This is a study planned to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.

Detailed Description

This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps and rubella at 35 days after administration of a single dose of MMR vaccine of Serum Institute of India.

Eligibility

Age

1 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Normal healthy infants of age 15-18 months at the time of the screening and have not received their first dose of MMR vaccine.
•2. Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record.
•3. Parents or legal guardians of subject willing to give written informed consent and willing to comply with study protocol.
•4. Free of obvious health problems as established by medical history and screening evaluation including clinical examination.

Exclusion Criteria

•1. Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
•2. Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
•3. Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
•4. Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.
•5. Clinical history of measles, mumps, or rubella infection.
•6. Infants with leukemia, lymphoma, or any other cancer or neoplasm.
•7. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, neurological, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives
•8. Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol.

Locations (6)

Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,

Visakhapatnam, Andhra Pradesh, India

Krishna Institute of Medical Sciences Deemed University,

Karad, Maharashtra, India

Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur

Pune, Maharashtra, India

Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,

Pune, Maharashtr, India

Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi

Pune, Maharasthra, India

Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,

Chennai, Tamil Nadu, India

Key Dates

Start Date

September 1, 2014

Primary Completion Date

February 1, 2016

Completion Date

February 1, 2016

Last Updated

March 14, 2018

Enrollment

341

ACTUAL participants

Conditions

Immune Response to MMR Vaccine

Interventions

MMR vaccine

BIOLOGICAL