Clinical trial NCT02253407: Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immune Response to MMR Vaccine
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PATH
First posted: 2014-10-01
Enrollment: 341
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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.

Primary outcomes:
measure: Seropositivity of individual child for measles, mumps and rubella
timeFrame: 35 days after administration of the study vaccines
Secondary outcomes:
measure: Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies
timeFrame: Day 35
measure: Solicited adverse reactions
timeFrame: Day 14
measure: Unsolicited adverse events
timeFrame: Day 35
measure: Serious adverse events (SAEs)
timeFrame: Day 35
Other outcomes:
Locations:
city: Visakhapatnam
country: India
facility: Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,
state: Andhra Pradesh
city: Karad
country: India
facility: Krishna Institute of Medical Sciences Deemed University,
state: Maharashtra
city: Pune
country: India
facility: Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur
state: Maharashtra
city: Pune
country: India
facility: Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
state: Maharashtr
city: Pune
country: India
facility: Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
state: Maharasthra
city: Chennai
country: India
facility: Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
state: Tamil Nadu
Study officials:
affiliation: Department of Pediatrics, KEM Hospital Research Centre, Pune, India
name: Ashish Bavdekar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India
name: Jitendra Oswal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bavdekar A, Oswal J, Ramanan PV, Aundhkar C, Venugopal P, Kapse D, Miller T, McGray S, Zehrung D, Kulkarni PS; SII MMR author group. Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial. Vaccine. 2018 Feb 21;36(9):1220-1226. doi: 10.1016/j.vaccine.2018.01.006. Epub 2018 Feb 1.