Meningitis, MeningococcalPhase 2NCT03587207

Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years

A Phase 2 study testing MenABCWY vaccine, rMenB+OMV NZ (Bexsero) vaccine and MenACWY (Menveo) vaccine in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the current study is to evaluate whether there is immune interference when MenABCWY [consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component] is administered to healthy adolescents and adults following a 2-dose vaccination schedule with MenABCWY administered 2 months… Read more about this study

Who is it for?: Ages 10 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal
What is being tested?: MenABCWY vaccine, rMenB+OMV NZ (Bexsero) vaccine and MenACWY (Menveo) vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 520 participants
Where: 1 siteCzechia
Study dates: 9 Jul 2018to 19 Dec 2018
Phase: Phase 2
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 10 to 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the paper diary (pDiary), return for follow-up visits, availability for all visits scheduled in the study).
Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure.
A male or female between, and including, 10 to 25 years of age at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.

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Non-childbearing potential is defined as pre menarche, current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced highly effective contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue highly effective contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Who cannot join

Female planning to become pregnant or planning to discontinue contraceptive precautions
Pregnant or lactating female
Child in care
Current or previous, confirmed or suspected disease caused by N. meningitidis.
Known contact to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to enrolment.
Previous vaccination against N. meningitidis at any time prior to informed consent.

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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.
Clinical conditions representing a contraindication to IM vaccination and blood draws.
Abnormal function of the immune system resulting from:
Clinical conditions.
Systemic administration of corticosteroids (oral/intravenous/IM) for more than 14 consecutive days within 90 days prior to informed consent.
Administration of antineoplastic and immune modulating agents or radiotherapy within 90 days prior to informed consent.
Received immunoglobulins or any blood products within 180 days prior to informed consent.
Received an investigational or non registered medicinal product within 30 days prior to informed consent.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non investigational vaccine/product.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Are obese at screening.
Family history of congenital or hereditary immunodeficiency.
History of neuroinflammatory or autoimmune condition.
History of significant neurological disorder or seizure.
Serious chronic illness.
History of chronic alcohol consumption and/or drug abuse.
Any study personnel as an immediate family or household member.
Administration of a vaccine not foreseen by the study protocol in the period starting 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) before each dose and ending 14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for influenza vaccines) after each dose of study vaccine(s) administration.
Thrombocytopenia, bleeding disorders, or be receiving anticoagulant therapy.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

GSK Investigational Site
Hradec Králové, 50002

Other trials in Czechia

About this study

Official title: Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone

Conditions: Meningitis, Meningococcal
Being tested: MenABCWY vaccine, rMenB+OMV NZ (Bexsero) vaccine, MenACWY (Menveo) vaccine
Keywords: Meningitis, Concomitantly, Adolescent, Neisseria meningitidis, Healthy subjects, Adult
Medical subject headings: Meningitis, Meningococcal, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MenABCWY vaccineBiological
Two doses administered intramuscularly in the deltoid region of the non-dominant arm.
rMenB+OMV NZ (Bexsero) vaccineBiological
Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group, rMenBOMV+ACWY_D Group and rMenBOMV Group
MenACWY (Menveo) vaccineBiological
Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group and rMenBOMV+ACWY_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group

Study groups in NCT03587207
Study group	Role	What they receive
MenABCWY Group	Experimental	Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61). Receives: Biological: MenABCWY vaccine
rMenBOMV+ACWY_S Group	Active comparator	Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61). Receives: Biological: rMenB+OMV NZ (Bexsero) vaccine; Biological: MenACWY (Menveo) vaccine
rMenBOMV+ACWY_D Group	Active comparator	Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61). Receives: Biological: rMenB+OMV NZ (Bexsero) vaccine; Biological: MenACWY (Menveo) vaccine
rMenBOMV Group	Active comparator	Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61). Receives: Biological: rMenB+OMV NZ (Bexsero) vaccine
MenACWY Group	Active comparator	Healthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group. Receives: Biological: MenACWY (Menveo) vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.
hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.
Measured: 1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.
hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.
Measured: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.
Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
Measured: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.
Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise was defined as: a) for individuals whose pre-vaccination titers were less than (<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
Measured: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.
hSBA mean ratios at 1 month after the last vaccination versus baseline were calculated in terms of GMRs i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after last vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.
Measured: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).

Secondary outcomes (9)

hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination
hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.
Measured: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.
hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.
Measured: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group.
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination
Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
Measured: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination
Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise is defined as: a) for individuals whose pre-vaccination titers were less than (<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
Measured: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination
hSBA mean ratios at 1 month after the first vaccination versus baseline were calculated in terms of GMRs. i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after first vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted mean were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.
Measured: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed local AEs were erythema, swelling, induration and pain. Any erythema, swelling and induration is defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
Measured: During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)
Number of Subjects With Any Solicited Systemic AEs
Assessed systemic AEs were arthralgia, fatigue, nausea, headache, myalgia and fever. Any fever is defined as body temperature equal or greater than 38 degrees Celsius.
Measured: During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)
Number of Subjects With Unsolicited AEs
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subjects/parent(s)/ Legally Acceptable Representative who has signed the informed consent or a solicited local or systemic adverse event that continues beyond the solicited period at day 7 after vaccination.
Measured: During the 30 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)
SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Medically attended AEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Measured: During the whole study period i.e from Day 1 to Day 91

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jul 201819 Dec 2018

First posted16 Jul 2018
Study start9 Jul 2018
Primary completion19 Dec 2018
Study completion19 Dec 2018

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 Meningitis, 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03587207
Sponsor's protocol ID: 208205
Other IDs: 2017-005128-12, 2017
Status last verified: Jan 2020
First submitted: 29 Jun 2018
Last updated: 12 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Beran J, Drazan D, Enweonye I, Bhusal C, Toneatto D. Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study of Adolescents and Young Adults. mSphere. 2021 Dec 22;6(6):e0055321. doi: 10.1128/mSphere.00553-21. Epub 2021 Nov 17.
PubMed 34787449

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone
ClinicalTrials.gov ID: NCT03587207
Acronym / sponsor ID: 208205
Conditions: Meningitis, Meningococcal
Keywords: Meningitis, Concomitantly, Adolescent, Neisseria meningitidis, Healthy subjects, Adult
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 520 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Jul 2018 (actual)
Primary completion: 19 Dec 2018 (actual)
Study completion: 19 Dec 2018 (actual)
First posted: 16 Jul 2018 (actual)
Results: Posted 2 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
MenABCWY Group	Experimental	Biological: MenABCWY vaccineHealthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenABCWY twice, 2 months apart (Day 1 and Day 61).
rMenBOMV+ACWY_S Group	Active comparator	Biological: rMenB+OMV NZ (Bexsero) vaccine, Biological: MenACWY (Menveo) vaccineHealthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in the same arm twice, 2 months apart (Day 1 and Day 61).
rMenBOMV+ACWY_D Group	Active comparator	Biological: rMenB+OMV NZ (Bexsero) vaccine, Biological: MenACWY (Menveo) vaccineHealthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) concomitantly received one dose of rMenB+OMV NZ (Bexsero) and one dose of MenACWY (Menveo) in 2 different arms twice, 2 months apart (Day 1 and Day 61).
rMenBOMV Group	Active comparator	Biological: rMenB+OMV NZ (Bexsero) vaccineHealthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of rMenB+OMV NZ (Bexsero) twice, 2 months apart (Day 1 and Day 61).
MenACWY Group	Active comparator	Biological: MenACWY (Menveo) vaccineHealthy subjects between, and including, 10 to 25 years of age at the time of the first vaccination (equally distributed across the 2 age strata of 10 to 17 years and 18 to 25 years) received one dose of MenACWY (Menveo) once at Day 1, which was the first and last vaccination for MenACWY group.

Who may qualify

Ages: 10 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the paper diary (pDiary), return for follow-up visits, availability for all visits scheduled in the study).
Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
Written informed assent obtained from subjects below the legal age of consent prior to performing any study specific procedure.
A male or female between, and including, 10 to 25 years of age at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (28 listed)

Female planning to become pregnant or planning to discontinue contraceptive precautions
Pregnant or lactating female
Child in care
Current or previous, confirmed or suspected disease caused by N. meningitidis.
Known contact to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to enrolment.

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
MenABCWY vaccineTwo doses administered intramuscularly in the deltoid region of the non-dominant arm.	Biological	MenABCWY Group
rMenB+OMV NZ (Bexsero) vaccineTwo doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group, rMenBOMV+ACWY_D Group and rMenBOMV Group	Biological	rMenBOMV Group, rMenBOMV+ACWY_D Group, rMenBOMV+ACWY_S Group
MenACWY (Menveo) vaccineTwo doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group and rMenBOMV+ACWY_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group	Biological	MenACWY Group, rMenBOMV+ACWY_D Group, rMenBOMV+ACWY_S Group

Primary outcome

Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.
Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group
hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.
Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.
hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.
Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.
Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.
Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.
Time frame: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).
Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise was defined as: a) for individuals whose pre-vaccination titers were less than (<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).
hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.
Time frame: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).
hSBA mean ratios at 1 month after the last vaccination versus baseline were calculated in terms of GMRs i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after last vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.

9 secondary outcomes

hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination
Time frame: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group
hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.
Time frame: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group.
Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination
Time frame: 1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group
Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination
Time frame: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)
hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination
Time frame: 1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Time frame: During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)
Number of Subjects With Any Solicited Systemic AEs
Time frame: During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)
Number of Subjects With Unsolicited AEs
Time frame: During the 30 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)
Time frame: During the whole study period i.e from Day 1 to Day 91

Results and safety

Results posted to the registry on 2 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MenABCWY Group	100	100
rMenBOMV+ACWY_S Group	104	104
rMenBOMV+ACWY_D Group	100	100
rMenBOMV Group	94	94
MenACWY Group	102	102

Primary outcome: Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.

Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group. Geometric mean (80% Confidence Interval). Unit: titers

Measure	MenABCWY Group n = 98	rMenBOMV+ACWY_S Group n = 100	rMenBOMV+ACWY_D Group n = 97	rMenBOMV Group n = 90
Value	31.84 (28.18 to 35.98)	38.48 (34.23 to 43.26)	40.08 (35.44 to 45.33)	42.38 (37.31 to 48.13)

rMenBOMV+ACWY_S Group vs rMenBOMV+ACWY_D Group: Geometric mean ratio: 0.96 (80% CI 0.83 to 1.10), ANCOVA

Population analysed: Analysis performed on Per Protocol Set(PPS) for immunogenicity that included subjects without major protocol violations \& whose assay results were available for atleast 1 serogroup/B strain at Day 91 for all study groups except MenACWY group that was not considered for this analysis as only serogroup B strains were assessed in this outcome measure

Primary outcome: hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.

Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.. Geometric mean (80% Confidence Interval). Unit: titers

Measure	MenABCWY Group n = 98	rMenBOMV+ACWY_S Group n = 101	rMenBOMV+ACWY_D Group n = 97	rMenBOMV Group n = 90	MenACWY Group n = 97
Meningitis B M14459 (fHbp)	23.91 (20.52 to 27.86)	23.34 (20.16 to 27.01)	23.23 (19.91 to 27.10)	22.87 (19.52 to 26.80)	2.48 (2.13 to 2.89)
Meningitis B 96217(NadA)	81.09 (69.24 to 94.97)	102.68 (88.24 to 119.50)	97.54 (83.18 to 114.39)	113.54 (96.25 to 133.93)	4.15 (3.54 to 4.86)
Meningitis B NZ98/254(PorA)	12.97 (10.89 to 15.45)	16.39 (13.86 to 19.39)	21.12 (17.71 to 25.18)	20.97 (17.47 to 25.16)	2.15 (1.81 to 2.57)
Meningitis B M07-0241084(NHBA)	13.08 (11.09 to 15.43)	18.00 (15.35 to 21.11)	22.59 (19.12 to 26.69)	25.34 (21.30 to 30.13)	4.08 (3.45 to 4.82)
Meningitis A	104.90 (87.02 to 126.47)	187.52 (156.94 to 224.05)	204.01 (169.06 to 246.18)	94.91 (78.26 to 115.12)	52.03 (43.01 to 62.95)
Meningitis C	172.99 (140.43 to 213.09)	144.80 (118.48 to 176.97)	145.42 (117.91 to 179.34)	32.01 (25.75 to 39.79)	34.66 (28.09 to 42.78)
Meningitis W	260.11 (219.31 to 308.51)	245.63 (208.40 to 289.52)	254.20 (213.76 to 302.30)	193.58 (161.68 to 231.76)	80.11 (67.42 to 95.19)
Meningitis Y	219.52 (173.10 to 278.39)	186.08 (148.25 to 233.55)	204.92 (161.40 to 260.16)	3.66 (2.86 to 4.69)	92.41 (72.75 to 117.37)

rMenBOMV+ACWY_S Group vs rMenBOMV+ACWY_D Group: Geometric mean ratio: 1.00 (80% CI 0.84 to 1.20), ANCOVA
rMenBOMV+ACWY_S Group vs rMenBOMV+ACWY_D Group: Geometric mean ratio: 1.05 (80% CI 0.88 to 1.26), ANCOVA
rMenBOMV+ACWY_S Group vs rMenBOMV+ACWY_D Group: Geometric mean ratio: 0.78 (80% CI 0.64 to 0.95), ANCOVA

Population analysed: Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain at Day 91 for all study groups except MenACWY Group or at Day 31 for the MenACWY Group.

Primary outcome: Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.

Time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.. Number (80% Confidence Interval). Unit: Percentage of subjects

Measure	MenABCWY Group n = 98	rMenBOMV+ACWY_S Group n = 101	rMenBOMV+ACWY_D Group n = 97	rMenBOMV Group n = 90	MenACWY Group n = 97
Meningitis B M14459 (fHbp)	83.5 (77.64 to 88.28)	86.0 (80.50 to 90.35)	88.5 (83.22 to 92.57)	83.3 (77.18 to 88.31)	12.4 (8.21 to 17.78)
Mengitis B 96217(NadA)	96.9 (93.31 to 98.87)	99.0 (96.17 to 99.89)	99.0 (96.05 to 99.89)	100.0 (97.47 to 100.00)	33.3 (26.96 to 40.24)
Meningitis B NZ98/254 (PorA)	59.2 (52.22 to 65.86)	76.0 (69.66 to 81.53)	80.4 (74.27 to 85.57)	78.7 (72.05 to 84.23)	5.2 (2.53 to 9.35)
Meningitis B M07-0241084 (NHBA)	59.2 (52.22 to 65.86)	74.0 (67.54 to 79.71)	77.1 (70.66 to 82.62)	80.9 (74.48 to 86.22)	23.2 (17.57 to 29.64)
Meningitis A	94.8 (90.65 to 97.47)	100.0 (97.75 to 100.00)	99.0 (96.05 to 99.89)	91.1 (85.96 to 94.76)	68.8 (61.86 to 75.15)
Meningitis C	100.0 (97.68 to 100.00)	100.0 (97.72 to 100.00)	100.0 (97.65 to 100.00)	96.7 (92.73 to 98.77)	86.6 (81.06 to 90.92)
Meningitis W	98.0 (94.66 to 99.46)	96.0 (92.17 to 98.24)	99.0 (96.01 to 99.89)	93.3 (88.59 to 96.46)	66.0 (59.09 to 72.36)
Menngitis Y	99.0 (96.05 to 99.89)	98.0 (94.77 to 99.47)	96.9 (93.24 to 98.86)	24.7 (18.79 to 31.54)	85.4 (79.71 to 89.94)

Primary outcome: Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.

Time frame: 1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).. Number (80% Confidence Interval). Unit: Percentage of subjects

Measure	MenABCWY Group n = 98	rMenBOMV+ACWY_S Group n = 100	rMenBOMV+ACWY_D Group n = 97	rMenBOMV Group n = 90	MenACWY Group n = 97
Meningitis B M14459 (fHbp)	66.0 (59.09 to 72.36)	69.0 (62.32 to 75.09)	66.3 (59.36 to 72.74)	63.3 (56.09 to 70.11)	2.1 (0.55 to 5.39)
Meningitis B 96217(NadA)	80.4 (74.27 to 85.57)	88.0 (82.74 to 92.04)	90.5 (85.46 to 94.20)	80.7 (74.20 to 86.06)	2.1 (0.56 to 5.45)
Meningitis B NZ98/254 (PorA)	48.0 (41.06 to 54.92)	60.0 (53.11 to 66.58)	58.8 (51.75 to 65.49)	60.7 (53.35 to 67.63)	1.0 (0.11 to 3.95)
Meningitis B M07-0241084(NHBA)	21.4 (16.10 to 27.68)	38.8 (32.18 to 45.72)	42.1 (35.27 to 49.20)	56.3 (48.88 to 63.54)	2.1 (0.57 to 5.56)
Meningitis A	92.7 (88.04 to 95.90)	99.0 (96.17 to 99.89)	98.9 (95.97 to 99.89)	87.8 (82.14 to 92.06)	67.4 (60.34 to 73.85)
Meningitis C	90.8 (85.89 to 94.38)	91.9 (87.21 to 95.24)	86.6 (81.06 to 90.92)	57.3 (49.95 to 64.40)	52.1 (45.05 to 59.05)
Meningitis W	83.3 (77.41 to 88.15)	78.6 (72.32 to 83.90)	74.2 (67.48 to 80.10)	74.1 (67.04 to 80.30)	41.1 (34.26 to 48.14)
Meningitis Y	95.9 (91.93 to 98.19)	91.9 (87.21 to 95.24)	93.7 (89.18 to 96.65)	11.4 (7.19 to 16.97)	76.8 (70.36 to 82.43)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited Adverse Events were reported during the 7 days post-vaccination period and Unsolicited Adverse Events during the 30 Days post-vaccination period. Serious Adverse Events: were reported during the whole study period (from Day 1 up to Day 91).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenABCWY Group	0 of 100 (0%)	94 of 100 (94%)	0 of 100
rMenBOMV+ACWY_S Group	2 of 104 (1.9%)	103 of 104 (99%)	0 of 104
rMenBOMV+ACWY_D Group	1 of 100 (1%)	98 of 100 (98%)	0 of 100
rMenBOMV Group	2 of 94 (2.1%)	94 of 94 (100%)	0 of 94
MenACWY Group	0 of 102 (0%)	80 of 102 (78.4%)	0 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34787449Beran J, Drazan D, Enweonye I, Bhusal C, Toneatto D. Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study of Adolescents and Young Adults. mSphere. 2021 Dec 22;6(6):e0055321. doi: 10.1128/mSphere.00553-21. Epub 2021 Nov 17.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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 (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MenABCWY vaccine, rMenB+OMV NZ (Bexsero) vaccine and MenACWY (Menveo) vaccine in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 1 site in Czechia.

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 11 inclusion and 28 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 12 Feb 2020. 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 Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2 Jan 2020). 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?

Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination. (time frame: 1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group). The study lists 5 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 NCT03587207, 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 12 Feb 2020.