MeningitisNCT02699840
Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation
An observational study of Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Russia.
Trial summary
The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation. Primary Objective: To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices. Read more about this study
- Who is it for?
- Ages 2 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- What is being tested?
- Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2016to 25 Jul 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants aged 2 to 55 years will be enrolled after receipt of one dose of Menactra® during a routine health care visit.
Who may be able to join
- Aged 2 through 55 years on the day of enrollment "2 through 55 years" means from the day of the 2nd birthday to the day before the 56th birthday
- For adults (18-55 years old) Informed consent form has been signed and dated by the participant.
- For minors: Informed consent form has been signed and dated by the parent. In addition, in accordance with the Institution Ethics Committee/Institution Review Board requirements and as appropriate for the age of the participant:
- participants aged 14 to 17 years are required to sign and date the informed consent form,
- participants aged 10 to 13 years are required to sign and date the assent form,
- for participants under 10 years, consent may be asked orally according to participant's age and ability for understanding
- Receipt of one dose of Menactra® on the day of inclusion and prior to enrollment into the study, in routine practice according to the approved local product insert.
Who cannot join
- Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra® Administered in Individuals 2 Through 55 Years Old Under Standard Health Care Practice in the Russian Federation
The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation.
Primary Objective:
- To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.
Read the detailed description
Participants will be enrolled after receipt of one dose of Menactra® during a routine health care visit. They will be monitored for safety throughout the study.
- Being tested
- Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Keywords
- Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine
- Medical subject headings
- Meningitis, Meningitis, Meningococcal, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®
No vaccine will be provided as part of this study
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®
No vaccine will be provided as part of this study
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®
No vaccine will be provided as part of this study
| Study group | Role | What they receive |
|---|---|---|
| Menactra Study Group 1 | Participant aged 2 through 11 years at vaccination Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | |
| Menactra Study Group 2 | Participant aged 12 through 17 years at vaccination Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | |
| Menactra Study Group 3 | Participant aged 18 through 55 years at vaccination Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine
Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia
Measured: Day 0 to Day 7 post-vaccination
Secondary outcomes (1)
Number of participants reporting unsolicited adverse events and serious adverse events after a single dose of Menactra® vaccine
Measured: Day 0 to Day 28 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion25 Jul 2016
- Study completion25 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699840
- Sponsor's protocol ID
- MTA92
- Other IDs
- U1111-1174-4339
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra® Administered in Individuals 2 Through 55 Years Old Under Standard Health Care Practice in the Russian Federation
- ClinicalTrials.gov ID
- NCT02699840
- Acronym / sponsor ID
- MTA92
- Keywords
- Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 25 Jul 2016 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 4 Mar 2016 (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 aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation.
Primary Objective:
- To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.
Detailed description
Participants will be enrolled after receipt of one dose of Menactra® during a routine health care visit. They will be monitored for safety throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menactra Study Group 1 | – | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineParticipant aged 2 through 11 years at vaccination |
| Menactra Study Group 2 | – | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineParticipant aged 12 through 17 years at vaccination |
| Menactra Study Group 3 | – | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineParticipant aged 18 through 55 years at vaccination |
Who may qualify
- Ages
- 2 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants aged 2 to 55 years will be enrolled after receipt of one dose of Menactra® during a routine health care visit.
Key inclusion criteria (7 listed)
- Aged 2 through 55 years on the day of enrollment "2 through 55 years" means from the day of the 2nd birthday to the day before the 56th birthday
- For adults (18-55 years old) Informed consent form has been signed and dated by the participant.
- For minors: Informed consent form has been signed and dated by the parent. In addition, in accordance with the Institution Ethics Committee/Institution Review Board requirements and as appropriate for the age of the participant:
- participants aged 14 to 17 years are required to sign and date the informed consent form,
- participants aged 10 to 13 years are required to sign and date the assent form,
Key exclusion criteria (1 listed)
- Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure.
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 |
|---|---|---|
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®No vaccine will be provided as part of this study | Biological | Menactra Study Group 1 |
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®No vaccine will be provided as part of this study | Biological | Menactra Study Group 2 |
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®No vaccine will be provided as part of this study | Biological | Menactra Study Group 3 |
Primary outcome
Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine
Time frame: Day 0 to Day 7 post-vaccination
Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia
1 secondary outcome
Number of participants reporting unsolicited adverse events and serious adverse events after a single dose of Menactra® vaccine
Time frame: Day 0 to Day 28 post-vaccination
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 25 Apr 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Medical Director study director
Sanofi Pasteur Russia
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 Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Russia.
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 7 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 25 Apr 2022. 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 Russia. 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?
Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine (time frame: Day 0 to Day 7 post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.