Meningococcal DiseasePhase 4NCT01823536
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
A Phase 4 study testing Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in people with Meningococcal Disease, run by Novartis Vaccines at 16 sites in 2 countries.
Trial summary
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20… Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 16 sitesin 2 countries
- Study dates
- May 2013to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- Subject has (a) parent(s) or legal guardian(s) who has/have given written consent after the nature of the study has been explained according to local regulatory requirements.
- If the subject is of an age where, according to local regulations, informed assent is required, that subject has provided assent to participate in the study.
- Subject is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator.
- A negative urine pregnancy test is required before female subjects of childbearing potential will be enrolled. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
- For subjects who participated in study V59P20 (Groups MenACWYCRM_ 2 (≥7-≤10 Years), MenACWYCRM_1 (≥7-≤10 Years) and MenACWYCRM_ 1 (≥11-≤15 Years) only):
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- subject who enrolled in Groups MenACWYCRM_2 (≥7-≤10 Years), MenACWYCRM_1 (≥7-≤10 Years) and MenACWYCRM_1 (≥11-≤15 Years) of study V59P20, has completed this study and included in per protocol immunogenicity analysis;
- the date of first vaccination in study V59P20 occurred 54 to 66 months prior to the collection of the blood sample at Visit 1.
- For vaccine-naive subjects (Groups Vaccine Naive(≥7-≤10Years) and Vaccine Naive (≥11-≤15 Years) only):
- Individual is a male or female 7 to 10 years of age (group Vaccine Naive(≥7-≤10Years)) or 11 to 15 years of age (Group Vaccine Naive (≥11-≤15 Years)).
Who cannot join
- In order to participate in this study, all subjects must meet NONE of the exclusion criteria described.
- If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
- Subject is a pregnant or breast-feeding female.
- Subjects' parents or legal guardians or subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- History of documented or suspected invasive meningococcal disease.
- Previous household contact with and/or intimate exposure to an individual with laboratory proven N. meningitidis infection within 60 days prior to enrollment and for the duration of the study.
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- Have received any other meningococcal vaccine since participation in V59P20 or, if vaccine-naive subjects, have not received any meningococcal vaccine since birth.
- Suspected or known hypersensitivity reaction after a previous dose of Menveo, any component of this vaccine, including any other CRM197 and diphtheria toxoid.
- Any contraindication or precaution against vaccination with Novartis Menveo™ vaccine as highlighted in the package insert.
- Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).
- Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
- Administration of any cancer chemotherapy, immune-modified or immunosuppressive agents or systemic corticosteroids for at least seven days at any dose in the past 12 weeks or planned use throughout the study period (nasal or inhaled steroids are permitted, as are steroids applied to the skin).
- Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the past 12 weeks or planned use throughout the study period.
- Administration of any vaccine within 28 days prior to the study enrollment or planned administration during the study period.
- Subjects participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the study period.
- Subjects who have experienced a significant acute infection requiring systemic antibiotic treatment within the 5 days prior to enrolment or have experienced a body temperature ≥38°C (≥100.4°F) within the 3 days before the intended study vaccination.
- Any condition which, in the opinion of the investigator, would pose a health risk to the participant.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
27 KY Pediatric Adult Research 201 South 5th Street, Suite 102
Bardstown, Kentucky, 40004
82 Children s Inv Research Prgm (ChIRP) 2900 Medical Center Parkway, Ste. 300
Bentonville, Arkansas, 72712
33 Dr. Sender's and Associates 2054 South Green Road
Cleveland, Ohio, 44121
65 Westside Medical 1477 N 2000 W, Suite C
Clinton, Utah, 84015
32 Prem Health Research Center 9317 Firestone Blvd.
Downey, California, 90241
31 Benchmark Research, Fort Worth 4504 Boat Club Rd., Suite 400A
Fort Worth, Texas, 76135
83 AR Pediatric Clinical Research 500 South University, Ste. 200
Little Rock, Arkansas, 72205
36 Meridian Clinical Research 3319 N. 107th Street
Omaha, Nebraska, 68134
29 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100
Salt Lake City, Utah, 84121
30 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100
Salt Lake City, Utah, 84121
25 Benchmark Research, San Angelo 3555 Knickerbocker Rd.
San Angelo, Texas, 76904
37 Copperview Medical Associates 3556 West 9800 South
South Jordan, Utah, 84095
34 Rockwood Clinic P S 400 East Fifth Avenue
Spokane, Washington, 99202
35 Rockwood Clinic-North Pediatrics 9001 N Country Homes Blvd
Spokane, Washington, 99218
47 Wee Care Pediatrics 1792 W. 1700 S.
Syracuse, Utah, 84075
Ukraine1 site
26 Benchmark Research 3800 Houma Blvd., Suite 345
Metairie, LA, 70006
About this study
Official title: A Phase IV, Open-label, Controlled, Multi-center Study to Evaluate the 5-year Antibody Persistence Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine at 2 to 10 Years of Age and to Assess the Immune Response to a Single Dose of Novartis MenACWY Conjugate Vaccine
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).
- Conditions
- Meningococcal Disease
- Being tested
- Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
- Keywords
- Meningitis
- Medical subject headings
- Meningococcal Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineBiological
Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
| Study group | Role | What they receive |
|---|---|---|
| MenACWY-CRM (≥7-≤10 years of age) | Experimental | Subjects, who had previously received 2 injections of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine |
| MenACWY-CRM_1 (≥7-≤10 years of age) | Experimental | Subjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine |
| Vaccine naive (≥7-≤10 years of age) | Experimental | Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine |
| MenACWY-CRM_1 (≥11-≤15 years of age) | Experimental | Subjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 7-10 years of age, were administered 1 injection of the same vaccine at 11-15 years of age. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine |
| Vaccine naive (≥11-≤15 years of age) | Experimental | Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine
The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.
The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA).
Measured: 5 years post-vaccination
Secondary outcomes (6)
Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.
The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.
Measured: 5 years post-vaccination
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects
The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects.
Measured: 5 years post-vaccination; baseline for naive
Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8.
Measured: Day 28 post-vaccination
Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs.
Measured: Day 28 post-vaccination
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,
- Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine
- Vaccine-naive subjects.
Measured: Day 1 to day 7 post-vaccination
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal.
Measured: Day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines and Diagnostics, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823536
- Sponsor's protocol ID
- V59P20E1
- Status last verified
- Jul 2014
- First submitted
- 28 Mar 2013
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.
PubMed 20943209
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label, Controlled, Multi-center Study to Evaluate the 5-year Antibody Persistence Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine at 2 to 10 Years of Age and to Assess the Immune Response to a Single Dose of Novartis MenACWY Conjugate Vaccine
- ClinicalTrials.gov ID
- NCT01823536
- Acronym / sponsor ID
- V59P20E1
- Conditions
- Meningococcal Disease
- Keywords
- Meningitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MenACWY-CRM (≥7-≤10 years of age) | Experimental | Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineSubjects, who had previously received 2 injections of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age. |
| MenACWY-CRM_1 (≥7-≤10 years of age) | Experimental | Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineSubjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age. |
| Vaccine naive (≥7-≤10 years of age) | Experimental | Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineVaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. |
| MenACWY-CRM_1 (≥11-≤15 years of age) | Experimental | Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineSubjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 7-10 years of age, were administered 1 injection of the same vaccine at 11-15 years of age. |
| Vaccine naive (≥11-≤15 years of age) | Experimental | Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineVaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- Subject has (a) parent(s) or legal guardian(s) who has/have given written consent after the nature of the study has been explained according to local regulatory requirements.
- If the subject is of an age where, according to local regulations, informed assent is required, that subject has provided assent to participate in the study.
- Subject is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator.
- A negative urine pregnancy test is required before female subjects of childbearing potential will be enrolled. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
Key exclusion criteria (17 listed)
- In order to participate in this study, all subjects must meet NONE of the exclusion criteria described.
- If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
- Subject is a pregnant or breast-feeding female.
- Subjects' parents or legal guardians or subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- History of documented or suspected invasive meningococcal disease.
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, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineSubjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. | Biological | MenACWY-CRM (≥7-≤10 years of age), MenACWY-CRM_1 (≥11-≤15 years of age), MenACWY-CRM_1 (≥7-≤10 years of age), Vaccine naive (≥11-≤15 years of age), Vaccine naive (≥7-≤10 years of age) |
Primary outcome
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine
Time frame: 5 years post-vaccination
The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA).
6 secondary outcomes
Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.
Time frame: 5 years post-vaccination
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects
Time frame: 5 years post-vaccination; baseline for naive
Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
Time frame: Day 28 post-vaccination
Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
Time frame: Day 28 post-vaccination
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
Time frame: Day 1 to day 7 post-vaccination
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
Time frame: Day 1 to day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20943209Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.
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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 and Diagnostics study chair
Novartis Vaccines
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in people with Meningococcal Disease, run by Novartis Vaccines at 16 sites in 2 countries.
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 10 inclusion and 17 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Ukraine. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine (time frame: 5 years post-vaccination). 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 NCT01823536, 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 15 Aug 2014.