Infections, MeningococcalPhase 3NCT02986854
Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
A Phase 3 study testing Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) in people with Infections, Meningococcal, run by GlaxoSmithKline at 37 sites in 2 countries.
Trial summary
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 704 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 8 Dec 2016to 7 Dec 2017
- Phase
- Phase 3
- 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals of 15 through 55 years of age on the day of informed consent or assent.
- Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine.
- Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
- Individuals who can comply with study procedures including follow-up.
- Males Or Females of non-childbearing potential Or
- Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
Who cannot join
- Each subject must not have:
- History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration.
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
Show all 18Show fewer
- Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws.
- Abnormal function of the immune system resulting from:
- Clinical conditions.
- Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
- Received immunoglobulins or any blood products within 180 days prior to informed consent.
- Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
- Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
- Study personnel as an immediate family or household member.
- Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
- Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States36 sites
GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Binghamton, New York, 13901
GSK Investigational Site
Birmingham, Alabama, 35211
GSK Investigational Site
Boise, Idaho, 83712
GSK Investigational Site
Centennial, Colorado, 80112
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Chicago, Illinois, 60604
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Draper, Utah, 84020
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Littleton, Colorado, 80128
GSK Investigational Site
Louisville, Kentucky, 40207
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Omaha, Nebraska, 68144
GSK Investigational Site
Pinellas Park, Florida, 33781
GSK Investigational Site
Plano, Texas, 75024
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95864
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
Salt Lake City, Utah, 84123
GSK Investigational Site
San Angelo, Texas, 76904
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Jose, California, 95119
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Tomball, Texas, 77375
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Wichita, Kansas, 67205-1138
GSK Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
Read the detailed description
This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and immunogenicity of Menveo after a single vaccination in healthy individuals who were vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals. Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to participation to this clinical trial.
Subjects will be randomised into one of the two different blood draw schedules according to a 1:1 ratio.
- Blood draws at Day 1, Day 4 and Day 29
- Blood draws at Day 1, Day 6 and Day 29
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
- Keywords
- Meningococcal disease, Booster vaccination, Meningitis, Antibody persistence
- 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 Vaccine (Menveo)Biological
One intramuscular injection of MenACWY at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Menveo-Menveo Group | Experimental | Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1. Receives: Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) |
| Menactra-Menveo Group | Experimental | Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1. Receives: Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) |
| Naive Group | Active comparator | Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1. Receives: Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.
Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo \&,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W \& Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo \& Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives
Measured: At Day 29
Secondary outcomes (16)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
Measured: Within 30 minutes after vaccination
Number of Subjects Reporting Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (<25 mm), Any (>= 25 mm)
Measured: From Day 1 (6 hours) through Day 7 after vaccination
Number of Subjects Reporting Other Indicators of Reactogenicity
Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)
Measured: From Day 1 (6 hours) through Day 7 after vaccination
Number of Subjects Reporting All Unsolicited AEs
An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
Measured: From Day 1 through Day 29 after vaccination
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)
Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.
Measured: From Day 1 through Day 181 (entire study period)
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Measured: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Measured: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Measured: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
Measured: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
Measured: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C
Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
Measured: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
Measured: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y
For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
Measured: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y
Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers <4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.
Measured: At Day 4 and Day 6
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.
For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.
Measured: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Within Group hSBA Geometric Mean Ratios (GMRs)
Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.
Measured: At Day 4, Day 6, Day 29 compared to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start8 Dec 2016
- Primary completion17 Jul 2017
- Study completion7 Dec 2017
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 Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986854
- Sponsor's protocol ID
- 205352
- Other IDs
- V59_77, 2016-003186-25, 2016
- Status last verified
- Nov 2019
- First submitted
- 6 Dec 2016
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Tipton M, Daly W, Senders S, Block SL, Lattanzi M, Mzolo T, Barbi S, Pellegrini M, Keshavan P. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.
PubMed 31495595
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
- ClinicalTrials.gov ID
- NCT02986854
- Acronym / sponsor ID
- 205352
- Conditions
- Infections, Meningococcal
- Keywords
- Meningococcal disease, Booster vaccination, Meningitis, Antibody persistence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Posted 3 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
Detailed description
This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and immunogenicity of Menveo after a single vaccination in healthy individuals who were vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals. Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to participation to this clinical trial.
Subjects will be randomised into one of the two different blood draw schedules according to a 1:1 ratio.
- Blood draws at Day 1, Day 4 and Day 29
- Blood draws at Day 1, Day 6 and Day 29
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menveo-Menveo Group | Experimental | Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1. |
| Menactra-Menveo Group | Experimental | Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1. |
| Naive Group | Active comparator | Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Individuals of 15 through 55 years of age on the day of informed consent or assent.
- Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine.
- Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
- Individuals who can comply with study procedures including follow-up.
- Males Or Females of non-childbearing potential Or
Key exclusion criteria (18 listed)
- History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration.
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
- Progressive, unstable or uncontrolled clinical conditions.
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
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 Vaccine (Menveo)One intramuscular injection of MenACWY at Day 1. | Biological | Menactra-Menveo Group, Menveo-Menveo Group, Naive Group |
Primary outcome
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.
Time frame: At Day 29
Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo \&,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W \& Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo \& Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives
16 secondary outcomes
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Time frame: Within 30 minutes after vaccination
Number of Subjects Reporting Solicited Local and Systemic AEs
Time frame: From Day 1 (6 hours) through Day 7 after vaccination
Number of Subjects Reporting Other Indicators of Reactogenicity
Time frame: From Day 1 (6 hours) through Day 7 after vaccination
Number of Subjects Reporting All Unsolicited AEs
Time frame: From Day 1 through Day 29 after vaccination
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)
Time frame: From Day 1 through Day 181 (entire study period)
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A
Time frame: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C
Time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C
Time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W
Time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y
Time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y
Time frame: At Day 4 and Day 6
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.
Time frame: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
Within Group hSBA Geometric Mean Ratios (GMRs)
Time frame: At Day 4, Day 6, Day 29 compared to Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31495595Tipton M, Daly W, Senders S, Block SL, Lattanzi M, Mzolo T, Barbi S, Pellegrini M, Keshavan P. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.
- Full CSR posting on GSKLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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.
GSK Clinical Trials study director
GlaxoSmithKline
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) in people with Infections, Meningococcal, run by GlaxoSmithKline at 37 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 6 inclusion and 18 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Aug 2018). 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 Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. (time frame: At Day 29). 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 NCT02986854, 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 25 Nov 2019.