Immune Response to MMR VaccinePhase 4NCT02253407
Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children
A Phase 4 study testing MMR vaccine in people with Immune Response to MMR Vaccine, run by Serum Institute of India Pvt. Ltd. at 6 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Immune Response to MMR Vaccine
- What is being tested?
- MMR vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 6 sitesIndia
- Study dates
- Sep 2014to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal healthy infants of age 15-18 months at the time of the screening and have not received their first dose of MMR vaccine.
- Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record.
- Parents or legal guardians of subject willing to give written informed consent and willing to comply with study protocol.
- Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
Who cannot join
- Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
- Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
- Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
- Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.
- Clinical history of measles, mumps, or rubella infection.
- Infants with leukemia, lymphoma, or any other cancer or neoplasm.
- 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
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
Chennai, Tamil Nadu, 600116
Krishna Institute of Medical Sciences Deemed University,
Karad, Maharashtra, 415110
Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Tal: Shirur
Pune, Maharashtra, 412216
Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
Pune, Maharashtr, 411011
Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
Pune, Maharasthra, 411043
Department of Paediatrics, Andhra Medical College, King George Hospital, Maharanipet,
Visakhapatnam, Andhra Pradesh, 530002
About this study
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
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.
Read the 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.
- Conditions
- Immune Response to MMR Vaccine
- Being tested
- MMR vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMR vaccineBiological
Also called Tresivac
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: MMR vaccine |
| 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 Receives: Biological: MMR vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 days after administration of the study vaccines
Secondary outcomes (4)
Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies
Measured: Day 35
Solicited adverse reactions
Measured: Day 14
Unsolicited adverse events
Measured: Day 35
Serious adverse events (SAEs)
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Response to MMR VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Responsible party
- Sponsor
- Investigators
- Ashish Bavdekar, MD, Principal investigator, Department of Pediatrics, KEM Hospital Research Centre, Pune, IndiaJitendra Oswal, MD, Principal investigator, Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253407
- Sponsor's protocol ID
- MMR-01/12
- Other IDs
- CTRI/2013/05/003702
- Status last verified
- Mar 2018
- First submitted
- 27 Sep 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29395526
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02253407
- Acronym / sponsor ID
- MMR-01/12
- Conditions
- Immune Response to MMR Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disposable syringe jet injector | Experimental | Biological: MMR vaccineSubjects 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. |
| Needle-Syringe | Active comparator | Biological: MMR vaccineSubjects 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 |
Who may qualify
- Ages
- 15 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Normal healthy infants of age 15-18 months at the time of the screening and have not received their first dose of MMR vaccine.
- Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record.
- Parents or legal guardians of subject willing to give written informed consent and willing to comply with study protocol.
- Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
Key exclusion criteria (8 listed)
- Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
- Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
- Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
- Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.
- Clinical history of measles, mumps, or rubella infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMR vaccineAlso: Tresivac | Biological | Disposable syringe jet injector, Needle-Syringe |
Primary outcome
Seropositivity of individual child for measles, mumps and rubella
Time frame: 35 days after administration of the study vaccines
Seropositivity of the individual child for particular vaccine component will be defined according to the levels given in the kit literature.
4 secondary outcomes
Comparison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies
Time frame: Day 35
Solicited adverse reactions
Time frame: Day 14
Unsolicited adverse events
Time frame: Day 35
Serious adverse events (SAEs)
Time frame: Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Results publication: PubMed 29395526Bavdekar 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.
Related trials for Immune Response to MMR Vaccine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashish Bavdekar, MD principal investigator
Department of Pediatrics, KEM Hospital Research Centre, Pune, India
Jitendra Oswal, MD principal investigator
Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MMR vaccine in people with Immune Response to MMR Vaccine, run by Serum Institute of India Pvt. Ltd. at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositivity of individual child for measles, mumps and rubella (time frame: 35 days after administration of the study vaccines). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.