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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2013/05/003702 | Registry Identifier | Clinical Trial Registry of India |
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| Name | Class |
|---|---|
| PATH | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disposable syringe jet injector | Experimental | Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc. |
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| Needle-Syringe | Active Comparator | Subjects in this arm will be given a single subcutaneous 0.5 mL dose of Serum Institute of India Ltd.'s MMR vaccine (Brand name: Tresivac) via conventional needle and Syringe |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMR vaccine | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity of individual child for measles, mumps and rubella | Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature. | 35 days after administration of the study vaccines |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies | Day 35 | |
| Solicited adverse reactions | Day 14 | |
| Unsolicited adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashish Bavdekar, MD | Department of Pediatrics, KEM Hospital Research Centre, Pune, India | Principal Investigator |
| Jitendra Oswal, MD | Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet, | Visakhapatnam | Andhra Pradesh | 530002 | India | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29395526 | Result | 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. |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Day 35 |
| Serious adverse events (SAEs) | Day 35 |
| Krishna Institute of Medical Sciences Deemed University, |
| Karad |
| Maharashtra |
| 415110 |
| India |
| Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur | Pune | Maharashtra | 412216 | India |
| Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, | Pune | Maharashtr | 411011 | India |
| Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi | Pune | Maharasthra | 411043 | India |
| Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur, | Chennai | Tamil Nadu | 600116 | India |
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |