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Meningitis, MeningococcalPhase 2NCT03433482

A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

A Phase 2 study testing MenACWY liquid and MenACWY in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 49 sites in 9 countries.

Completed

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

Official record
Search all trials

Trial summary

MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries. Read more about this study

Who is it for?
Ages 10 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Meningitis, Meningococcal
What is being tested?
MenACWY liquid and MenACWY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,707 participants
Where
49 sitesin 9 countries
Study dates
30 Aug 2018to 17 Dec 2019
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
  • Written informed assent obtained for subjects below legal age of consent, if required by local regulations at the time of the enrolment.
  • A male or female ≥10 to ≤40 YoA at the time of the 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, bilateral ovariectomy or post-menopause
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period.

Who cannot join

  • Child in care
  • Anaphylaxis following the administration of vaccine.
  • Any (clinical) condition that in the judgment of the investigator would make intramuscular injection unsafe \&/represents a contraindication to intramuscular vaccination and blood draws.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
  • 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 27Show fewer
  • Hypersensitivity to the active substances or to any of the excipients of the vaccine, including diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components.
  • Abnormal function of the immune system resulting from:
  • Clinical conditions.
  • Systemic administration of corticosteroids within 90 days prior to informed consent, and until the Day 29 blood draw.
  • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent, and until the Day 29 blood draw.
  • 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 pose additional risk to the subject due to participation in the study.
  • History of any meningococcal vaccination, with the exception of previous meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age.
  • Individuals who received any other vaccines within 7 days (for inactivated vaccines) or 14 days prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.*
  • In case an emergency mass vaccination for an unforeseen public health threat is organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its Prescribing Information and according to the local governmental recommendations and provided a written approval of the sponsor is obtained.
  • Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
  • 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 (pharmaceutical product or device).
  • 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.
  • Acute disease and/or fever within 3 days prior to study vaccination. Note: enrolment may be postponed/delayed until such transient circumstances have ended.
  • Fever is defined as body temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
  • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
  • Study personnel as an immediate family or household member.
  • Pregnant or lactating women.

Trial locations and contacts

49 sites in 9 countries.

49 sites in 9 countries

Spain13 sites

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona

  • GSK Investigational Site

    Centelles (Barcelona), 08540

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Quart de Poblet, Valencia, 46930

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Valencia, 46011

  • GSK Investigational Site

    Valencia, 46022

  • GSK Investigational Site

    Valencia, 46200

  • GSK Investigational Site

    Valencia

  • GSK Investigational Site

    Vic/ Barcelona, 08500

Other trials in Spain

Russia10 sites

  • GSK Investigational Site

    Gatchina, 188300

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Murmansk, 183038

  • GSK Investigational Site

    Saint Petersburg, 191025

  • GSK Investigational Site

    Saint Petersburg, 196240

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197089

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Yaroslavl, 150051

  • GSK Investigational Site

    Yekaterinburg, 620028

Other trials in Russia

Finland6 sites

  • GSK Investigational Site

    Espoo, 02230

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Pori, 28100

  • GSK Investigational Site

    Tampere, 33100

Other trials in Finland

Brazil5 sites

  • GSK Investigational Site

    Natal, Rio Grande do Norte, 59025-050

  • GSK Investigational Site

    Rio de Janeiro, 22271-100

  • GSK Investigational Site

    Salvador, Estado de Bahia, 40420-000

  • GSK Investigational Site

    São Paulo, 01228-200

  • GSK Investigational Site

    São Paulo, 04266-010

Other trials in Brazil

France5 sites

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Nantes, 44277

  • GSK Investigational Site

    Nice, 06300

  • GSK Investigational Site

    Rosiers-d'Égletons, 19300

  • GSK Investigational Site

    Tours, 37044

Other trials in France

Estonia4 sites

  • GSK Investigational Site

    Tallinn, 10117

  • GSK Investigational Site

    Tallinn, 11313

  • GSK Investigational Site

    Tallinn

  • GSK Investigational Site

    Tartu, 50106

Other trials in Estonia

Mexico2 sites

  • GSK Investigational Site

    Durango, 34000

  • GSK Investigational Site

    Mérida, Yucatán, 97070

Other trials in Mexico

South Africa2 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Pretoria, Gauteng, 0152

Other trials in South Africa

Turkey (Türkiye)2 sites

  • GSK Investigational Site

    Eskişehir, 26040

  • GSK Investigational Site

    Izmir, 35340

Other trials in Turkey (Türkiye)

About this study

Official title: Immunogenicity, Reactogenicity and Safety Study of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) When Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.

The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.

Being tested
MenACWY liquid, MenACWY
Keywords
Meningococcal disease, Liquid formulation, Meningitis
Medical subject headings
Meningitis, Meningococcal, Meningococcal Infections, Meningitis

What participants receive

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

  • MenACWY liquidBiological

    At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.

  • MenACWYBiological

    Also called Menveo

    At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY_1) or in phase 2 of the study (subjects randomized to study arm ACWY_2), administered by intramuscular injection in the deltoid of the non-dominant arm.

Study groups in NCT03433482
Study groupRoleWhat they receive
GSK3536820A ACWY_Liq24 GroupExperimentalHealthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1.
Receives: Biological: MenACWY liquid
ACWY_1 GroupActive comparatorHealthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.
Receives: Biological: MenACWY
GSK3536820A ACWY_Liq30 GroupExperimentalHealthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.
Receives: Biological: MenACWY liquid
ACWY_2 GroupActive comparatorHealthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Receives: Biological: MenACWY

What is being measured

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

  1. Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios

    hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.

    Measured: At Day 29

Secondary outcomes (10)

  1. hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios

    hSBA titers were calculated in terms of GMTs, at Day 1 and Day 29, against each of the N. meningitidis serogroup A, C, W and Y.

    Measured: At Day 1 and Day 29

  2. Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group

    Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y at Day 29 compared to Day 1.

    Measured: At Day 29

  3. Percentages of Subjects With ≥4 Fold Rise in hSBA Antibody Titers for Each of the N.Meningitidis Serogroups A, C,W and Y for Each Vaccine Group and Between-group Differences

    The percentages of subjects with a ≥ 4-fold rise in post-vaccination hSBA (at Day 29 compared to Day 1) and associated 2-sided 95% Clopper-Pearson CIs are computed by group and N. meningitidis serogroups A, C, W and Y. A 4-fold rise in the hSBA titers is defined as: - for individuals, whose pre-vaccination titers are < the LOD (limit of detection), the post-vaccination titers must be ≥ 4-fold the LOD or ≥ the LLOQ (lower limit of quantitation) whichever is greater; - for individuals whose pre-vaccination titers are ≥ the LOD and ≤ the LLOQ, the post-vaccination titers must be at least four times the LLOQ; - for individuals whose pre-vaccination titers are > the LLOQ, the post-vaccination titers must be at least four times the pre-vaccination titer.

    Measured: At Day 29

  4. Percentages of Subjects With hSBA Antibody Titers ≥8 Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Differences

    For each vaccine group the percentage of subjects with hSBA titer ≥8 , and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.

    Measured: At Day 1 and Day 29

  5. Percentages of Subjects With hSBA Titers ≥LLOQ Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences

    For each vaccine group the percentages of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.

    Measured: At Day 1 and Day 29

  6. Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination

    An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.

    Measured: Within 30 minutes after vaccination at Day 1

  7. Number of Subjects Reported With Solicited Local and Systemic AEs

    Assessed solicited local AEs were erythema, induration and pain at injection site. Assessed solicited systemic AEs were Arthralgia, chills, fatigue, fever (body temperature ≥38.0°C), headache, loss of appetite, myalgia and nausea.

    Measured: From Day 1 (6 hours) to Day 7 after vaccination

  8. Number of Subjects Reported With Other Indicators of Reactogenicity

    Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after any vaccination

    Measured: From Day 1 to Day 7 after vaccination

  9. Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination

    An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.

    Measured: From Day 1 to Day 29 after vaccination

  10. Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs

    Medically attended AEs are defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) is occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. Serious adverse event is any congenital anomaly/birth defect in the offspring of a study subject or any untoward medical occurrence that results in death or life threatening or requires hospitalization or results in disability or incapacity

    Measured: From Day 1 to Day 181 (during the entire study period)

Timeline

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

  1. First posted14 Feb 2018
  2. Study start30 Aug 2018
  3. Primary completion26 Jul 2019
  4. Study completion17 Dec 2019

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03433482
Sponsor's protocol ID
207467
Other IDs
V59_78, 2017-003456-23, 2017
Status last verified
Jan 2021
First submitted
8 Feb 2018
Last updated
17 Feb 2021
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Vir Singh P, Tiberi P, Di Domenico GF, Romolini V, Mzolo T, Costantini M, Akhund T, Basile V, Lattanzi M, Pellegrini M. Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis. Drug Saf. 2023 Jan;46(1):99-108. doi: 10.1007/s40264-022-01242-8. Epub 2022 Nov 11.

    PubMed 36369456

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MenACWY liquid and MenACWY in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 49 sites in 9 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 11 inclusion and 27 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Spain, Russia, Finland, Brazil, France and 4 more countries. 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 17 Feb 2021). 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?

Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios (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 NCT03433482, 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 17 Feb 2021.

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