Meningococcal DiseaseNCT01452438
Safety Surveillance of MenACWY-CRM Vaccine in Children
An observational study of Meningococcal Disease, run by Novartis Vaccines at 1 site in United States.
Trial summary
The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- MenACWY-CRM
- Type of treatment
- Vaccines
- How many people
- 393 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2015
- Phase
- Observational
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population is selected from the Health Maintenance Organization population of the Kaiser Permanente Southern California (KPSC) HMO in Pasadena, CA, USA.
Who may be able to join
- Registered with the HMO for at least 6 months prior to vaccination.
- Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination.
- Received any MenACWY-CRM vaccination during the vaccination period at the participating centers.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente South California
Pasadena, California, 91101
About this study
Official title: Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age
The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.
Read the detailed description
This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited.
Events of Interest: Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Intentional Injury
- Conditions
- Meningococcal Disease
- Being tested
- MenACWY-CRM
- Keywords
- observational, serogroup A, B, Y, W, meningococcal meningitis, meningococcal vaccines, safety, MenACYW-CRM, post-marketing, children
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenACWY-CRMBiological
MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.
| Study group | Role | What they receive |
|---|---|---|
| MenACYW-CRM vaccinated children | All children between the age of 2 to 10 years old who have received of MenACYW-CRM vaccine during the study period. Receives: Biological: MenACWY-CRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest
Measured: Observational period of 1 year following date of vaccination of that individual.
Frequency (n, %) for all serious medically attended events and events of interest
Measured: Observational period of 1 year following date of vaccination of that individual.
Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest
Measured: Observational period of 1 year following date of vaccination of that individual.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJul 2015
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 Meningococcal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452438
- Sponsor's protocol ID
- V59_54OB
- Status last verified
- Aug 2015
- First submitted
- 29 Sep 2011
- Last updated
- 6 Aug 2015
- Results posted
- No
Publications
Tartof SY, Sy LS, Ackerson BK, Hechter RC, Haag M, Slezak JM, Luo Y, Fischetti CA, Takhar HS, Miao Y, Solano Z, Jacobsen SJ, Tseng HF. Safety of Quadrivalent Meningococcal Conjugate Vaccine in Children 2-10 Years. Pediatr Infect Dis J. 2017 Nov;36(11):1087-1092. doi: 10.1097/INF.0000000000001696.
PubMed 28719502
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age
- ClinicalTrials.gov ID
- NCT01452438
- Acronym / sponsor ID
- V59_54OB
- Conditions
- Meningococcal Disease
- Keywords
- observational, serogroup A, B, Y, W, meningococcal meningitis, meningococcal vaccines, safety, MenACYW-CRM, post-marketing, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Oct 2011 (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.
The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.
Detailed description
This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited.
Events of Interest: Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Intentional Injury
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MenACYW-CRM vaccinated children | – | Biological: MenACWY-CRMAll children between the age of 2 to 10 years old who have received of MenACYW-CRM vaccine during the study period. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population is selected from the Health Maintenance Organization population of the Kaiser Permanente Southern California (KPSC) HMO in Pasadena, CA, USA.
Key inclusion criteria (3 listed)
- Registered with the HMO for at least 6 months prior to vaccination.
- Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination.
- Received any MenACWY-CRM vaccination during the vaccination period at the participating centers.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MenACWY-CRMMenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records. | Biological | MenACYW-CRM vaccinated children |
Primary outcome
Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest
Time frame: Observational period of 1 year following date of vaccination of that individual.
Frequency (n, %) for all serious medically attended events and events of interest
Time frame: Observational period of 1 year following date of vaccination of that individual.
Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest
Time frame: Observational period of 1 year following date of vaccination of that individual.
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 6 Aug 2015.
- Derived from this study: PubMed 28719502Tartof SY, Sy LS, Ackerson BK, Hechter RC, Haag M, Slezak JM, Luo Y, Fischetti CA, Takhar HS, Miao Y, Solano Z, Jacobsen SJ, Tseng HF. Safety of Quadrivalent Meningococcal Conjugate Vaccine in Children 2-10 Years. Pediatr Infect Dis J. 2017 Nov;36(11):1087-1092. doi: 10.1097/INF.0000000000001696.
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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.
Novartis Vaccines study chair
Novartis Vaccines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal Disease, run by Novartis Vaccines at 1 site in United States.
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 3 inclusion and 1 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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest (time frame: Observational period of 1 year following date of vaccination of that individual.). The study lists 3 primary outcomes in all. 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 NCT01452438, 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 6 Aug 2015.